FDA 510(k) Applications for Medical Device Product Code "DXN"
(System, Measurement, Blood-Pressure, Non-Invasive)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K141160 | A & D CO., LTD. | A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR | 10/07/2014 |
| K141201 | A & D CO., LTD. | A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR | 10/08/2014 |
| K141179 | A & D CO., LTD. | A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR | 06/27/2014 |
| K032499 | A & D ENGINEERING, INC. | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | 10/30/2003 |
| K012472 | A & D ENGINEERING, INC. | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | 02/15/2002 |
| K040371 | A & D ENGINEERING, INC. | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | 05/19/2004 |
| K061456 | A & D ENGINEERING, INC. | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | 06/21/2006 |
| K993888 | A & D ENGINEERING, INC. | A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS | 12/20/1999 |
| K960319 | A & D ENGINEERING, INC. | A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR | 07/02/1996 |
| K040229 | A & D ENGINEERING, INC. | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | 03/19/2004 |
| K042967 | A & D ENGINEERING, INC. | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | 12/03/2004 |
| K002115 | A & D ENGINEERING, INC. | A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS | 07/25/2000 |
| K043217 | A & D ENGINEERING, INC. | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | 03/03/2005 |
| K982481 | A & D ENGINEERING, INC. | A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR | 09/25/1998 |
| K062027 | A & D ENGINEERING, INC. | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | 01/19/2007 |
| K082734 | A & D ENGINEERING, INC. | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | 11/13/2008 |
| K980824 | A & D ENGINEERING, INC. | A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR | 03/19/1998 |
| K010828 | A & D ENGINEERING, INC. | DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP | 03/29/2001 |
| K012013 | A & D ENGINEERING, INC. | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | 07/13/2001 |
| K040410 | A C COSSOR & SON (SURGICAL) LIMITED | GREENLIGHT 300 | 05/05/2004 |
| K173065 | A&D Company, Ltd | A&D Medical Blood Pressure Monitors | 04/24/2019 |
| K151953 | A&D COMPANY, LTD | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | 04/13/2016 |
| K163683 | A&D COMPANY, LTD | A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | 05/03/2017 |
| K212168 | A&D Company, Ltd | A&D Medical UM-212BLE Blood Pressure Monitor | 10/06/2022 |
| K111686 | A&D COMPANY, LTD. | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | 08/01/2011 |
| K173191 | A&D Company, Ltd. | A&D Medical Blood Pressure Monitors | 03/21/2019 |
| K170196 | A&D Company, Ltd. | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | 05/17/2017 |
| K992808 | A&D MEDICAL DIV. | A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE | 09/01/1999 |
| K112273 | ACCUMED HEALTHCARE (SHANGHAI) INC. | ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR | 11/22/2011 |
| K112270 | ACCUMED HEALTHCARE (SHANGHAI) INC. | ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR | 11/22/2011 |
| K222658 | Accurate Meditech Inc. | Accurate 24 Non-invasive blood pressure monitor | 06/21/2023 |
| K242352 | Accurate Meditech Inc. | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | 02/05/2025 |
| K060925 | ACON LABORATORIES, INC. | ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112 | 05/09/2006 |
| K122076 | ADFLOW HEALTH NETWORKS INC | PERSONAL HEALTH CENTER (PHC) | 04/15/2013 |
| K162230 | ADON HEALTH CO., LTD. | Fully Automatic Electronic Blood Pressure Monitor | 11/18/2016 |
| K964697 | ADVANCE MEDICAL DEVICE, INC. | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION | 02/11/1997 |
| K983717 | AEROTEL MEDICAL SYSTEMS (1998) LTD. | BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM | 09/16/1999 |
| K030825 | AEROTEL MEDICAL SYSTEMS (1998) LTD. | MPM-NET | 03/28/2003 |
| K021447 | AEROTEL MEDICAL SYSTEMS (1998) LTD. | TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM | 05/22/2002 |
| K041854 | AEROTEL MEDICAL SYSTEMS, LTD. | MPM SYSTEM | 10/06/2004 |
| K123882 | AGELESS HEALTH INDUSTRIAL | AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR | 08/14/2013 |
| K153552 | Ageless Health Industrial Co., Ltd | AGE Automatic Upper Arm Blood Pressure Monitor | 06/01/2016 |
| K172895 | Ageless Health Industrial Co., Ltd | AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 | 06/18/2018 |
| K103058 | AGUIFLAI IBERICA S.L. | MULTIFUNCTION KEITO | 11/10/2011 |
| K250415 | Aktiia SA | G0 Blood Pressure Monitoring System (G0) | 07/02/2025 |
| K974061 | ALEXANDER MFG. CO. | RECHARGEABLE BATTERY PART NUMBER GL825-200 | 01/16/1998 |
| K180435 | Alicn Medical (Shenzhen), Inc | Arm Blood Pressure Monitor | 01/03/2019 |
| K231050 | Alicn Medical Shenzhen, Inc | Arm Blood Pressure Monitor | 10/11/2023 |
| K230649 | Alicn Medical Shenzhen, Inc | Arm Blood Pressure Monitor | 09/07/2023 |
| K210563 | Alicn Medical Shenzhen,Inc | Arm Blood Pressure Monitor | 10/15/2021 |
| K212877 | Alicn Medical Shenzhen,Inc | Arm Blood Pressure Monitor | 01/12/2022 |
| K221913 | Alicn Medical Shenzhen,Inc | Arm Blood Pressure Monitor | 10/12/2022 |
| K952882 | AMERICAN TELECARE, INC. | PERSONAL TELEMEDICINE SYSTEM | 09/09/1996 |
| K012796 | AMLUCK, INC. | AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 | 03/14/2002 |
| K050413 | AMPLIFE CORPORATION | AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 | 03/04/2005 |
| K043550 | AMPLIFE CORPORATION | AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 | 01/27/2005 |
| K051903 | ANALOGIC CORPORATION | FETALGARD LITE-NIBP, MODEL FGL-NIBP | 12/27/2005 |
| K234041 | Andon Health Co Ltd | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Ful | 04/22/2024 |
| K122098 | ANDON HEALTH CO., LTD | APPS-HEALTH01 | 03/21/2013 |
| K171282 | Andon Health Co., Ltd | Fully Automatic Blood Pressure Monitor | 07/27/2017 |
| K141984 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 04/29/2015 |
| K110018 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 03/15/2011 |
| K121372 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 09/10/2012 |
| K140121 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 07/02/2014 |
| K160563 | ANDON HEALTH CO., LTD | Fully Automatic Electronic Blood Pressure Monitor | 08/04/2016 |
| K160565 | ANDON HEALTH CO., LTD | Fully Automatic Electronic Blood Pressure Monitor | 08/10/2016 |
| K111830 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO | 12/09/2011 |
| K121470 | ANDON HEALTH CO., LTD | FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR | 06/14/2012 |
| K131203 | ANDON HEALTH CO., LTD | IHEALTH CLOUD | 07/19/2013 |
| K160014 | Andon Health Co., Ltd | iHealth Track Blood Pressure Monitor | 02/02/2016 |
| K222869 | Andon Health Co., Ltd. | Arm Blood Pressure Monitor | 02/15/2023 |
| K210770 | Andon Health Co., Ltd. | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | 07/29/2021 |
| K171062 | Andon Health Co., Ltd. | BP5S Wireless Blood Pressure Monitor | 08/01/2017 |
| K151460 | ANDON HEALTH CO., LTD. | Fully Automatic Electronic Blood Pressure Monitor | 09/08/2015 |
| K162915 | Andon Health Co., Ltd. | Fully Automatic Electronic Blood Pressure Monitor | 02/08/2017 |
| K183534 | Andon Health Co., Ltd. | Fully Automatic Electronic Blood Pressure Monitor | 05/16/2019 |
| K183535 | Andon Health Co., Ltd. | Fully Automatic Electronic Blood Pressure Monitor | 06/04/2019 |
| K210768 | Andon Health Co., Ltd. | Wrist Blood Pressure Monitor, Blood Pressure Monitor | 07/30/2021 |
| K083246 | ANDON HEALTH CO.,LTD | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 | 01/29/2009 |
| K083248 | ANDON HEALTH CO.,LTD | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 | 01/29/2009 |
| K083247 | ANDON HEALTH CO.,LTD | FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 | 01/29/2009 |
| K090772 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 | 06/04/2009 |
| K090770 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 | 06/04/2009 |
| K090771 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 | 06/04/2009 |
| K102930 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 11/03/2010 |
| K111826 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 12/09/2011 |
| K163276 | ANDON HEALTH CO.,LTD | Fully Automatic Electronic Blood Pressure Monitor | 05/11/2017 |
| K102690 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 11/24/2010 |
| K102906 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 10/29/2010 |
| K110330 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 02/18/2011 |
| K162668 | ANDON HEALTH CO.,LTD | Fully Automatic Electronic Blood Pressure Monitor | 02/14/2017 |
| K102353 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 | 09/17/2010 |
| K093452 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 | 12/23/2009 |
| K093387 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 | 11/27/2009 |
| K093528 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 | 12/04/2009 |
| K101950 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 | 08/31/2010 |
| K102939 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 | 02/23/2011 |
| K102356 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 | 09/20/2010 |
| K101010 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 | 07/30/2010 |
| K090963 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 | 04/30/2009 |
| K100014 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 | 01/29/2010 |
| K083317 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 | 01/29/2009 |
| K083318 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 | 01/29/2009 |
| K092588 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 | 12/29/2009 |
| K100940 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 | 06/29/2010 |
| K083319 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 | 01/29/2009 |
| K090769 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 | 06/04/2009 |
| K091997 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 | 07/30/2009 |
| K090768 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, | 06/04/2009 |
| K092811 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 | 01/13/2010 |
| K092045 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 | 07/30/2009 |
| K092510 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 | 12/23/2009 |
| K091737 | ANDON HEALTH CO.,LTD | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 | 08/18/2009 |
| K152003 | ANDON HEALTH CO.,LTD | iHealth BP3L Wireless Blood Pressure Monitor | 09/24/2015 |
| K152379 | ANDON HEALTH CO.,LTD | iHealth View BP7S Wireless Blood Pressure Wrist Monitor | 09/23/2015 |
| K162144 | ANDON HEALTH CO.,LTD | iHealth Wireless Blood Pressure Monitor | 02/01/2017 |
| K080326 | ANDON HEALTH CO.,LTD | KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 07/31/2008 |
| K080319 | ANDON HEALTH CO.,LTD | KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 07/02/2008 |
| K102631 | ANDON HEALTH CO.,LTD | KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 11/04/2010 |
| K120672 | ANDON HEALTH CO.,LTD | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR | 06/01/2012 |
| K091500 | ANDON HEALTH CO.,LTD | MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 | 07/31/2009 |
| K091738 | ANDON HEALTH CO.,LTD | SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD | 08/18/2009 |
| K091739 | ANDON HEALTH CO.,LTD | SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 | 08/18/2009 |
| K083395 | ANDON HEALTH CO.,LTD | SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 | 02/27/2009 |
| K102609 | ANDON MEDICAL CO., LTD. | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | 12/09/2010 |
| K040159 | ASIA PACIFIC MICROSYSTEMS, INC. | APM BLOOD PRESSURE MONITOR, MODEL BP108A | 03/22/2004 |
| K221742 | Atcor Medical | CONNEQT PULSE | 04/21/2023 |
| K122129 | ATCOR MEDICAL | SPHYGMOCOR XCEL | 11/16/2012 |
| K012487 | ATCOR MEDICAL PTY. LTD | SPHYGMOCOR PX MODEL SCOR-PX | 02/21/2002 |
| K210152 | AVICHE Shandong Medical Technology Co, Ltd. | Automatic Digital Blood Pressure Monitor | 09/23/2021 |
| K011779 | AVID CARE CORP. | AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM | 07/13/2001 |
| K010029 | AVID CARE CORP. | HOME HEALTH MONITORING SYSTEM | 06/29/2001 |
| K180155 | Avita Corporation | Arm Type Blood Pressure Monitor | 08/03/2018 |
| K242193 | AViTA Corporation | Arm Type Blood Pressure Monitor (BPM82) | 10/22/2024 |
| K112825 | AVITA CORPORATION | AVITA ARM TYPE BLOOD PRESSURE MONITOR | 01/18/2012 |
| K072137 | AVITA CORPORATION | AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB | 12/07/2007 |
| K030230 | AVITA CORPORATION | AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) | 05/23/2003 |
| K033397 | AVITA CORPORATION | AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY | 04/09/2004 |
| K102624 | AVITA CORPORATION | AVITA WRIST TYPE BLOOD PRESSURE MONITOR | 12/16/2010 |
| K200346 | Avita Corporation | Wrist Type Blood Pressure Monitor | 12/17/2020 |
| K983796 | BCI INTL., INC. | 6004 NIBP MONITOR WITH TEMPERATURE | 01/22/1999 |
| K984618 | BCI INTL., INC. | BCI MINI-TORR PLUS, MODEL 6004 | 03/25/1999 |
| K970801 | BCI INTL., INC. | BCI MODEL 6004 NIBP MONITOR (6004) | 11/12/1997 |
| K162089 | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | Blood Pressure Monitor | 02/10/2017 |
| K093013 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | BLOOD PRESSURE MONITOR, MODEL MD200A | 01/08/2010 |
| K241066 | BioBeat Technologies Ltd. | BB-613-BPM | 01/14/2025 |
| K141924 | BIOCARE ASIA CORPORATION LTD. | HD BLOOD PRESSURE MONITOR | 09/08/2014 |
| K091414 | BIOCARE CORP. | VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH | 10/21/2009 |
| K081498 | BIOCOMFORT DIAGNOSTICS GMBH & CO. KG | TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 | 12/17/2008 |
| K083681 | BIOLAND TECHNOLOGY LTD. | BIOLAND BLOOD PRESSURE MONITOR | 01/16/2009 |
| K202934 | Bioland Technology Ltd. | Blood Pressure Monitor | 01/26/2021 |
| K201467 | Bioland Technology Ltd. | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | 09/21/2020 |
| K122443 | BIOSIGN TECHNOLOGIES, INC. | UFIT TEN-10 | 11/20/2012 |
| K131064 | BIOSPACE CORPORATION LIMITED | BIOSPACE | 09/04/2013 |
| K021029 | BIOTRAC, INC. | ABP-2000 G-3 | 04/12/2002 |
| K072049 | BMEYE B.V. | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS | 11/29/2007 |
| K101123 | BMEYE B.V. | NEXFIN MODEL 2 | 10/28/2010 |
| K012035 | BRAUN GMBH | BRAUN PRECISION SENSOR PRO, MODEL BP 2590 | 07/27/2001 |
| K003732 | BRAUN GMBH | BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES | 05/16/2001 |
| K100913 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | IQVITALS AND IQVITALS SYSTEM | 05/26/2010 |
| K984083 | BUMEDCO INTL., INC. | MULTIFUNCTION KEITO K5 | 01/18/2000 |
| K081924 | CALHEALTH INC | CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE | 01/07/2009 |
| K041169 | CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. | PIESOMETER, MODEL MK-1 | 08/24/2004 |
| K053395 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | BP PRO BLOOD PRESSURE MONITOR | 12/23/2005 |
| K060703 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | PMP4 BP PRO BLOOD PRESSURE MONITOR | 04/04/2006 |
| K043096 | CARDIOCOM | COMMANDER II | 11/24/2004 |
| K053303 | CARDIOCOM LLC | CARDIOCOM COMMANDER III | 12/30/2005 |
| K091821 | CARDIOCOM LLC | COMMANDER 111, MODEL CD300-CD399 | 08/25/2009 |
| K053304 | CARDIOCOM LLC | COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM | 12/30/2005 |
| K123020 | CAREMATIX INC. | BLIP MODEL BP-700WF | 11/28/2012 |
| K031840 | CAREMATIX INC. | CAREMATIX WELLNESS SYSTEM | 10/10/2003 |
| K211588 | Caretaker Medical | Caretaker Platform, VitalStream Platform, CT5 | 08/13/2021 |
| K151499 | CARETAKER MEDICAL, LLC | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor | 03/18/2016 |
| K163255 | Caretaker Medical, LLC | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | 04/21/2017 |
| K213699 | Caretaker Medical, LLC | CareTaker Monitor App | 03/30/2022 |
| K982135 | CAS MEDICAL SYSTEMS, INC. | OSCILLOMATE EMS NIBP MONITOR MODEL 9001 | 09/15/1998 |
| K251102 | Cemho Medical Technology (Guangdong) Co., Ltd. | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | 07/16/2025 |
| K100553 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER MODEL CH-101 | 05/25/2010 |
| K093931 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER, MODEL CH-4532 | 06/10/2010 |
| K100055 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER, MODEL CH-609 | 08/30/2010 |
| K102303 | CITIZEN SYSTEMS JAPAN CO., LTD. | BLOOD PRESSURE METER, MODEL CH-658 | 09/10/2010 |
| K061161 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODEL CH-311B | 06/26/2006 |
| K052046 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODEL CH-432 | 10/19/2005 |
| K984223 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 | 04/28/1999 |
| K001244 | CITIZEN WATCH CO., LTD. | BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D | 09/26/2000 |
| K954547 | CITIZEN WATCH CO., LTD. | CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER | 04/01/1997 |
| K973061 | CITIZEN WATCH CO., LTD. | CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) | 03/13/1998 |
| K093981 | Cnoga Medical LTD | YRNSORTIP OXIMANOMETER | 07/22/2010 |
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| K092683 | SHANGHAI LITTLE DOCTOR CO. LIMITED | DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 | 09/25/2009 |
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| K191180 | Shenzhen AOJ Medical Technology Co., Ltd. | Electronic Blood Pressure Monitor | 08/23/2019 |
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| K241613 | Shenzhen HBcare Technology Co.,Ltd | Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) | 10/16/2024 |
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| K243118 | Shenzhen IMDK Medical Technology Co., Ltd. | Arm Blood Pressure Monitor (model: BPM-A7VL) | 11/26/2024 |
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| K233146 | Shenzhen Jamr Technology Co., Ltd. | Blood Pressure Monitor | 03/19/2024 |
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| K220886 | Shenzhen Jamr Technology Co.,Ltd | Upper Arm Type Blood Pressure Monitor | 07/27/2022 |
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| K102988 | SHENZHEN PANGO ELECTRONIC CO., LTD | ELECTRONIC BLOOD PRESURE MONITOR | 11/09/2010 |
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| K200716 | Shenzhen Pango Electronic Co., Ltd. | Electronic Blood Pressure Monitor | 12/04/2020 |
| K161845 | Shenzhen Pango Electronic Co.,Ltd. | Electronic Blood Pressure Monitor | 07/31/2017 |
| K223291 | Shenzhen Pango Medical Electronics Co., Ltd. | Electronic Blood Pressure Monitor | 06/14/2023 |
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| K161708 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD | Arm automatic blood pressure monitor | 11/22/2016 |
| K161712 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | Arm automatic blood pressure monitor | 04/05/2017 |
| K151258 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | Arm automatic blood pressure monitor | 02/18/2016 |
| K130325 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | ARM AUTOMATIC BLOOD PRESSURE MONITOR | 12/24/2013 |
| K141416 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | BLOOD PRESSURE MONITOR | 10/09/2014 |
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| K160019 | SHENZHEN URION TECHNOLOGY CO.,LTD | U80 Series Upper Arm Electronic Blood Pressure Monitor | 04/22/2016 |
| K241007 | Shenzhen Urion Technology Co.,Ltd. | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | 10/24/2024 |
| K243115 | Shenzhen Urion Technology Co.,Ltd. | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, | 02/21/2025 |
| K193348 | Shenzhen Viatom Technology Co., Ltd. | Blood Pressure Monitor | 06/25/2020 |
| K190207 | Shenzhen Viatom Technology Co., Ltd. | Blood Pressure Monitor | 08/19/2019 |
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| K230176 | Shenzhen Yolanda Technology Co., Ltd. | Upper Arm Blood Pressure Monitor | 06/29/2023 |
| K222926 | Shenzhen Yuezhongxing Technology Co., Ltd. | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | 05/05/2023 |
| K233799 | Shenzhen Yuezhongxing Technology Co., Ltd. | Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | 03/15/2024 |
| K211041 | Shenzhen Yuezhongxing Technology Co., Ltd. | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | 08/30/2021 |
| K191894 | ShenZhen ZhengKang Technology Co., Ltd. | Upper Arm Blood Pressure Monitor | 02/21/2020 |
| K242568 | Shenzhen Zhongkemingwang Telecommunications Software Corp. | Wrist Blood Pressure Monitor (OHMS11, OHMS12) | 01/30/2025 |
| K152831 | SKANRAY TECHNOLOGIES PRIVATE LIMITED | Spot Skan | 02/23/2016 |
| K150908 | Sky Innovation Technology ( Shanghai) Limited | XM-01 Electronic Automatic Blood Pressure Monitor | 12/16/2015 |
| K113402 | SOLOHEALTH, INC. | SOLOHEALTH STATION | 05/30/2012 |
| K103732 | SPACELABS HEALTHCARE LTD. | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR | 02/04/2011 |
| K141113 | SPACELABS HEALTHCARE LTD. | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | 09/26/2014 |
| K123539 | STAYHEALTHY, INC. | STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK | 04/22/2013 |
| K103693 | SUMMIT DOPPLER SYSTEMS, INC. | VANTAGE ABI | 02/15/2011 |
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| K151520 | SunTech Medical, Inc. | Oscar 2 | 02/19/2016 |
| K122401 | SUNTECH MEDICAL, INC. | TANGO M2 BLOOD PRESSURE MONITOR | 11/02/2012 |
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| K153033 | SUZHOU SUNSPIRI CO., LTD. | Digital Blood Pressure Monitor | 06/24/2016 |
| K152415 | SUZHOU SUNSPIRIT CO., LTD. | Digital Blood Pressure Monitor | 05/06/2016 |
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| K051703 | TaiDoc Technology Corporation | CLEVER TD-3018A BLOOD PRESSURE MONITOR | 08/12/2005 |
| K073445 | TaiDoc Technology Corporation | CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 | 04/02/2008 |
| K182934 | TaiDoc Technology Corporation | FORA P100 Blood Pressure Monitoring System | 02/12/2019 |
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| K112274 | TaiDoc Technology Corporation | U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM | 12/21/2011 |
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| K041491 | ZEWA, INC. | ZEWA MFM-007 BLOOD PRESSURE MONITOR | 09/20/2004 |
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| K120058 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK BLOOD PRESSURE MONITOR | 01/31/2012 |
| K123780 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK BLOOD PRESSURE MONITOR | 03/01/2013 |
| K101681 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 | 05/27/2011 |
| K122482 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK WRIST BLOOD PRESSURE MONITOR | 10/22/2012 |
| K123669 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. | TRANSTEK WRIST BLOOD PRESSURE MONITOR | 12/21/2012 |
| K220220 | Zhuhai Linte Medical Instrument Co., Ltd. | Electronic Sphygmomanometer (Model: LT-P30) | 10/03/2022 |
| K232814 | Zhuhai Yueja Medical Device Technology Co.,Ltd. | Electronic Blood Pressure Monitor | 12/05/2023 |
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| K040012 | ZOE MEDICAL, INC. | WELL@HOME SYSTEM | 04/02/2004 |
| K032363 | ZOLL MEDICAL CORP. | ZOLL M SERIES NIBP OPTION | 10/31/2003 |
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