FDA 510(k) Applications for Medical Device Product Code "CCK"
(Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131506 | ABEON MEDICAL CORPORATION | AIRWAY SUPPORT SYSTEM / AIRPORT | 03/06/2014 |
| K142467 | ABEON MEDICAL CORPORATION | IntelAir Nasal Airway Support System | 11/24/2014 |
| K031741 | ALARIS MEDICAL SYSTEMS, INC. | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | 02/09/2004 |
| K991086 | BCI INTL., INC. | CAPNOCHECK II, MODEL 8400 | 06/09/1999 |
| K970209 | BCI INTL., INC. | CAPNOCHECK PLUS | 04/18/1997 |
| K030407 | BCI, INC. | ADVISOR, MODEL 9200 | 08/19/2003 |
| K192446 | Beijing Kingst Commercial & Trade Co.,Ltd. | CO2 Mainstream Module | 05/21/2020 |
| K192488 | Beijing Kingst Commercial & Trade Co.,Ltd. | CO2 Sidestream Module | 05/22/2020 |
| K143150 | BESMED HEALTH BUSINESS CORP. | CO2 monitoring line with and without in-line filter | 02/05/2015 |
| K190824 | Bluepoint Medical GmbH & Co. KG | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric | 12/18/2019 |
| K000520 | BREGAS AB | C-IT | 05/16/2000 |
| K023820 | BREGAS AB | CO2 CLIP | 05/07/2003 |
| K120518 | CAREFUSION | END TIDAL CO2 NASAL CANNULA | 05/04/2012 |
| K170820 | CMI Health Inc. | Capnograph and Oximeter | 07/18/2018 |
| K203762 | Covidien | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | 09/17/2021 |
| K213518 | Covidien llc | CARESCAPE CO2 Microstream parameter | 04/12/2022 |
| K213911 | Covidien LLC | Microstream CO2 NanoPod | 07/29/2022 |
| K980384 | DATEX-ENGSTROM, INC. | TRIP TONOMETRY CATHETER, 18F | 05/01/1998 |
| K001814 | DATEX-OHMEDA | DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES | 08/23/2000 |
| K023454 | DATEX-OHMEDA | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES | 04/23/2003 |
| K993656 | DATEX-OHMEDA, INC. | DATEX-OHMEDA TONOMETRY MODULE M-TONO | 03/15/2000 |
| K143127 | DISPO-MED (MALAYSIA) SDN BHD | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style | 02/13/2015 |
| K100941 | DRAEGER MEDICAL AG & CO. KG | INFINITY MCABLE - MAINSTREAM CO2 | 04/23/2010 |
| K053204 | DRAEGER MEDICAL AG & CO. KGAA | INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A | 02/03/2006 |
| K040847 | DRAEGER MEDICAL, INC. | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | 06/17/2004 |
| K012139 | DRAEGER MEDICAL, INC. | VAMOS ANESTHETIC GAS MONITOR | 01/17/2002 |
| K221118 | Draegerwerk AG & Co. KGaA | CO2 Mainstream Sensor | 04/05/2023 |
| K041956 | DRAEGET MEDICAL AG & CO. KGAA | EMG - ESSENTIAL GAS MODULE, MODEL M1013A | 08/09/2004 |
| K213767 | Endure Industries Inc | Endure ETCO2/02 Nasal Cannula | 09/12/2023 |
| K220533 | Engineered Medical Systems Inc. | Endoscopy Oxygen Mask | 11/16/2022 |
| K133516 | FLEXICARE | CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER | 04/30/2014 |
| K140473 | FLEXICARE MEDICAL LTD. | DUALGUARD | 04/10/2014 |
| K140113 | FLEXICARE MEDICAL LTD. | O2 NASAL CANNULA WITH CO2 MONITORING | 03/06/2014 |
| K980979 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE | 06/12/1998 |
| K052880 | GE HEALTHCARE | DATEX-OHMEDA S/5 INTERFACE MODULE E-INT | 11/02/2005 |
| K052582 | GE HEALTHCARE | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES | 10/14/2005 |
| K052167 | GE HEALTHCARE | DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES | 09/08/2005 |
| K211171 | GE Healthcare Finland Oy | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | 10/21/2021 |
| K183394 | GE Healthcare Finland Oy | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | 05/01/2019 |
| K150245 | GE HEALTHCARE FINLAND OY | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX | 07/17/2015 |
| K171028 | GE Healthcare Finland OY | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories | 08/17/2017 |
| K961150 | HUDSON RESPIRATORY CARE, INC. | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | 09/10/1996 |
| K954402 | ICOR AB | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | 05/22/1996 |
| K962638 | INSTRUMENTARIUM CORP. | TONOCAP, TC-200 AND ACCESSORY CATHETERS | 04/04/1997 |
| K122075 | INTERSURGICAL, INC. | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | 12/20/2012 |
| K964961 | IVY BIOMEDICAL SYSTEMS, INC. | MODEL 405T WITH ETCO2 OPTION | 05/14/1997 |
| K983114 | MAGNA ADVANCED TECHNOLOGIES, INC. | MAGNATEK80 | 09/22/1998 |
| K982846 | MAGNA ADVANCED TECHNOLOGIES, INC. | MTEK-1400 | 09/18/1998 |
| K954120 | MAGNETIC RESONANCE EQUIPMENT CORP. | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR | 04/02/1997 |
| K003982 | MAGNETIC RESONANCE EQUIPMENT CORP. | TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR | 01/26/2001 |
| K050066 | MARQUEST MEDICAL PRODUCTS, INC. | C-CO2 COLORIMETRIC CO2 INDICATOR | 03/01/2005 |
| K960972 | MARQUEST MEDICAL PRODUCTS, INC. | DISPOSABLE GAS SAMPLING INTERFACE KITS | 10/18/1996 |
| K973984 | MARQUETTE MEDICAL SYSTEMS, INC. | RAC 2A MODULE HOUSING | 01/16/1998 |
| K201590 | Masimo Corporation | EMMA Capnograph | 03/29/2021 |
| K133540 | MAXTEC, INC. | FLOCAP | 03/28/2014 |
| K182362 | Maxtec, LLC | MaxCap Ped and MaxCap Neo | 05/23/2019 |
| K000712 | MEDICAL RESEARCH LABORATORIES, INC. | PORTABLE INTENSIVE CARE UNIT, MODEL PIC | 04/27/2000 |
| K180902 | MediPines Corporation | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | 01/11/2019 |
| K131339 | MEDIPLUS LTD. | CAPNOMASK | 11/25/2013 |
| K192563 | Meditera Tibbi Malzeme San. ve Tic. A.S. | Altera gas Sampling Lines | 01/17/2020 |
| K971229 | MEDSYS, INC. | CAPNOXYGEN MASK | 09/23/1997 |
| K983864 | MENNEN MEDICAL, INC. | ETCO2 VITAL SIGNS MODULE | 10/08/1999 |
| K021576 | MERCURY MEDICAL | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 | 11/04/2002 |
| K031411 | MERCURY MEDICAL | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 | 07/30/2003 |
| K083056 | MERCURY MEDICAL | NEO-STAT CO2 | 02/23/2009 |
|
| K031814 | MERCURY MEDICAL | STATCO2METER, MODEL 10-55372 | 08/14/2003 |
| K133806 | MONITOR MASK, INC. | M1 CAPNOGRAPHY MASK | 12/31/2013 |
| K040875 | NIHON KOHDEN AMERICA, INC. | CAP-ONE, MODEL TG-920P | 10/15/2004 |
| K062115 | NIHON KOHDEN AMERICA, INC. | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | 12/27/2006 |
| K020046 | NIHON KOHDEN AMERICA, INC. | MULTIGAS UNIT, MODEL AG-920RA | 07/25/2002 |
| K083456 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | 03/02/2009 |
| K964305 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES | 02/19/1997 |
| K990063 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | 06/09/1999 |
| K072843 | NIHON KOHDEN AMERICA, INC. | YG-125T AND YG-135T NASAL ADAPTER | 11/29/2007 |
| K110594 | NIHON KOHDEN CORP. | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS | 10/28/2011 |
| K122214 | NIHON KOHDEN CORP. | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) | 05/21/2013 |
| K171765 | Nihon Kohden Corporation | Nihon Kohden CO2 Monitor | 10/11/2017 |
| K161860 | NIHON KOHDEN CORPORATION | TG-970P CO2 Sensor Kit | 02/24/2017 |
| K982969 | NONIN MEDICAL, INC. | NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 | 08/12/1999 |
| K963327 | NOVAMETRIX MEDICAL SYSTEMS, INC. | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | 11/20/1996 |
| K984579 | OPTICAL SENSORS, INC. | CAPNO PROBE A | 12/21/2000 |
| K010795 | OPTICAL SENSORS, INC. | CAPNOPROBE SL, MODEL 2000 | 04/11/2001 |
| K171828 | Orantech Inc. | ETCO2 Sensor | 05/31/2018 |
| K094012 | ORIDION CAPNOGRAPHY, INC. | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE | 05/12/2010 |
| K040011 | ORIDION LTD. | POLARIS 2004 CAPNOGRAPH | 05/13/2004 |
| K150272 | ORIDION MEDICAL 1987 LTD. | Capnostream 35 Portable Respiratory Monitor | 07/17/2015 |
| K200594 | Oridion Medical 1987 Ltd. | Capnostream 35 Portable Respiratory Monitor | 04/27/2020 |
| K112368 | ORIDION MEDICAL 1987 LTD. | CAPNOSTREAM20P WITH AI/ODI | 07/19/2012 |
| K123690 | ORIDION MEDICAL 1987 LTD. | CAPNOSTREAM20P WITH HIFI C02 MONITORING | 08/05/2014 |
| K012395 | ORIDION MEDICAL 1987 LTD. | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | 08/15/2001 |
| K012391 | ORIDION MEDICAL 1987 LTD. | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | 08/15/2001 |
| K181624 | Oridion Medical 1987 Ltd. | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | 03/22/2019 |
| K002163 | ORIDION MEDICAL 1987 LTD. | MICROSTREAM EXTERNAL BATTERY CHARGER | 01/11/2001 |
| K121927 | ORIDION MEDICAL 1987 LTD. | MICROSTREAM FILTERLINE ICU | 11/29/2012 |
| K181467 | Oridion Medical 1987 Ltd. | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | 02/08/2019 |
| K011536 | ORIDION MEDICAL 1987 LTD. | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | 11/14/2001 |
| K011050 | ORIDION MEDICAL 1987 LTD. | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | 05/04/2001 |
| K013845 | ORIDION MEDICAL 1987 LTD. | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | 11/29/2001 |
| K010024 | ORIDION MEDICAL 1987 LTD. | O2/CO2 NASAL FILTERLINE | 03/14/2001 |
| K012394 | ORIDION MEDICAL 1987 LTD. | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | 08/15/2001 |
| K042665 | ORIDION MEDICAL 1987 LTD. | SMART BITEBLOC | 11/23/2004 |
| K093388 | ORIDION MEDICAL 1987 LTD. | SMART CAPNOLINE GUARDIAN | 03/04/2010 |
| K981114 | ORIDION MEDICAL LTD. | MICROCAP | 06/25/1998 |
| K980324 | ORIDION MEDICAL LTD. | MICROSTREAM FILLERLINE OR/EMS | 04/16/1998 |
| K980327 | ORIDION MEDICAL LTD. | MICROSTREAM FILTERLINE ICU | 04/16/1998 |
| K980325 | ORIDION MEDICAL LTD. | MICROSTREAM NASAL CANNULA FILTERLINE | 04/16/1998 |
| K072813 | PHASEIN AB | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) | 12/28/2007 |
| K063167 | PHASEIN AB | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) | 02/06/2007 |
| K123043 | PHASEIN AB | IRMA C02 MODEL 200101; IRMA AX 200601 | 10/25/2012 |
| K103604 | PHASEIN AB | ISA CO2, ISA AX+, ISA OR+ | 04/06/2011 |
| K081601 | PHASEIN AB | VEO MULTIGAS MONITOR FOR POCKET PC | 09/04/2008 |
| K172904 | Philips Medizin Systeme Boeblingen GmbH | IntelliVue Capnography Extension, IntelliVue Microstream Extension | 12/26/2017 |
| K210112 | Pneuma Therapeutics, Inc. | XChange Device, XChange System | 01/30/2023 |
| K172365 | Pom Medical, LLC | Panoramic Oxygen Mask (POM) | 04/19/2018 |
| K053063 | PRO-TECH SERVICES, INC. | PRO-FLOW MULTIPURPOSE CANNULA | 12/13/2005 |
| K023579 | PROMEDIC, INC. | GAS SAMPLING LINES | 01/28/2003 |
| K171235 | Respirion, Inc. | OmniCap | 01/04/2018 |
| K053174 | RESPIRONICS NOVAMETRIX LLC | LOFLO C5 CO2 SENSOR | 01/12/2006 |
| K042601 | RESPIRONICS NOVAMETRIX, INC. | CAPNOSTAT 5 | 11/19/2004 |
| K041450 | RESPIRONICS NOVAMETRIX, INC. | MODIFICATION TO NICO WITH MARS, MODEL 7300 | 06/18/2004 |
| K030886 | RESPIRONICS NOVAMETRIX, INC. | NICO WITH MARS, MODEL 7300 | 10/07/2003 |
| K173147 | Revolutionary Medical Devices, Inc. | SuperNO2VA Et Device | 06/20/2018 |
| K151421 | Salter Labs | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | 03/10/2016 |
| K112840 | SEEBREATH AB | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR | 07/13/2012 |
| K003550 | SIEMENS MEDICAL SOLUTIONS USA, INC. | INFINITY ETCO2 + RESPIRATORY MECHANICS POD | 03/07/2001 |
| K992116 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SIEMEMNS INFINITY ETC02 POD | 01/12/2000 |
| K954632 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SIEMENS SC 9000 ETCO2 MODULE | 02/05/1996 |
| K131410 | SOUTHMEDIC, INC. | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), | 01/13/2014 |
| K014211 | SOUTHMEDIC, INC. | OXYARM CO2 | 06/11/2002 |
| K130112 | SPACELABS HEALTHCARE | CAPNO MODULE, 92517 | 03/21/2013 |
| K121017 | SPACELABS HEALTHCARE | CAPNOGRAPHY PAD (92516) | 07/13/2012 |
| K964239 | SPEGAS INDUSTRIES, LTD. | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER | 05/09/1997 |
| K132946 | Teleflex Medical, Inc. | SOFTECH PLUS ETC02 CANNULA | 06/04/2014 |
| K143469 | TELEFLEX MEDICAL, INC. | SOFTECH Plus ETCO2 Cannula | 02/12/2015 |
| K080527 | TRAWAX PTY LIMITED | TWINGUARD WITH CAPNOGRAPH ACCESSORY | 10/31/2008 |
| K181981 | Tylenol Medical Instruments Co., Ltd | CO2 Sampling Line | 02/06/2019 |
| K210019 | Unimed Medical Supplies, Inc. | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ | 03/04/2021 |
| K973544 | VACUMED, DIV. OF VACUMETRICS, INC. | VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER | 05/26/1998 |
| K093525 | VENTLAB CORP. | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE | 12/10/2009 |
| K063813 | VENTLAB CORP. | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | 03/26/2008 |
| K161250 | Venture Therapeutics, Inc. | OC-FLEX Flexible IntraOral Cannula | 03/17/2017 |
| K171678 | Vyaire Medical, Inc. | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m | 04/30/2018 |
| K051857 | WEISSBURG ASSOCIATES | VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 | 09/15/2005 |
| K070128 | Westmed, Inc. | CO2 EASY | 02/15/2007 |
| K072220 | Westmed, Inc. | PEDI CO2 EASY | 08/23/2007 |
| K162343 | WESTMED, INC. | Westmed Gas Sampling Cannula with O2 delivery | 12/14/2016 |
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