FDA 510(k) Applications for Medical Device Product Code "CAW"
(Generator, Oxygen, Portable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991569 | 02 MARKETING GROUP, INC. | HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 | 08/03/1999 |
| K200496 | 3B Medical Inc. | Aer X | 07/24/2020 |
| K960309 | AIRSEP CORP. | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) | 02/28/1997 |
| K101154 | AIRSEP CORP. | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L | 03/28/2011 |
| K012037 | AIRSEP CORP. | HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 | 01/17/2002 |
| K020324 | AIRSEP CORP. | LIFESTYLE OXYGEN CONCENTRATOR | 03/13/2002 |
| K150930 | AirSep Corporation | Deployable Oxygen Generation System-Smaill (DOGS-S) | 12/18/2015 |
| K971129 | ARBOR RESEARCH CORP. | OXYPURE PORTABLE OXYGEN GENERATOR | 06/24/1997 |
| K203086 | Belluscura LLC | X-PLO2R | 03/02/2021 |
| K121167 | CAIRE INC. | CAIRE COMPANION 5 OXYGEN CONCENTRATOR | 05/02/2012 |
| K120785 | CAIRE, INC. | OMNI 3 OXYGEN SYSTEM | 10/25/2012 |
| K982243 | CANOGEN INTERNATIONAL LTD. | CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 | 11/19/1998 |
| K071904 | CARLETON LIFE SUPPORT SYSTEMS INC. | DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) | 10/25/2007 |
| K051887 | CARLETON LIFE SUPPORT SYSTEMS INC. | PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) | 09/27/2005 |
| K971889 | CHAD THERAPEUTICS, INC. | CHAD TOTAL O2 DELIVERY SYSTEM | 11/17/1997 |
| K013472 | CHAD THERAPEUTICS, INC. | TOTAL O2 | 11/28/2001 |
| K981047 | COLORADO MEDTECH, INC. | FRESH AIR | 09/16/1999 |
| K180837 | Contec Medical System Co., Ltd. | CONTEC Oxygen Concentrator | 01/10/2019 |
| K071461 | COPD PARTNERS, INC. | MODEL 300D HOME OXYGEN LIQUEFIER | 08/21/2007 |
| K090007 | DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. | JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 | 07/24/2009 |
| K073242 | DELPHI MEDICAL SYSTEMS | PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 | 01/03/2008 |
| K172648 | DeVilbiss Healthcare, LLC | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | 03/23/2018 |
| K043520 | EMG TECHNOLOGY CO., LTD. | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | 10/21/2005 |
| K984081 | EMOX 911 CC | EMOX | 03/17/1999 |
| K131990 | ESSEX CRYOGENICS OF MISSOURI, INC. | OXYGEN GENERATOR LIQUEFIER - (OGL) | 02/21/2014 |
| K022684 | ESSEX CRYOGENICS OF MISSOURI, INC. | PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) | 09/11/2002 |
| K102245 | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. | CARE ZY5BA OXYGEN CONCENTRATOR | 11/09/2010 |
| K202389 | Foshan MIC Medical Technology Co., LTD | Oxygen Concentrator | 04/08/2022 |
| K102750 | GETO2, INC. | O2-IN-A-BOX, O2-IN-A-BOX | 02/11/2011 |
| K191875 | Guangzhou Life Light Electronic Technology Co., Ltd. | Owgels Oxygen Concentrator | 07/20/2020 |
| K972614 | HEALTHDYNE TECHNOLOGIES, INC. | TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 | 01/20/1998 |
| K004047 | IN-X CORP. | HOME-AWAY SYSTEM | 12/18/2001 |
| K042944 | IN-X CORPORATION | HOME-AWAY SYSTEM, MODEL 1041 | 04/15/2005 |
| K222086 | Inogen | Inogen Rove 4 Portable Oxygen Concentrator | 12/09/2022 |
| K230052 | Inogen, Inc | Inogen Rove 6 | 06/30/2023 |
| K132489 | INOGEN, INC. | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) | 06/20/2014 |
| K032818 | INOGEN, INC. | INOGEN ONE OXYGEN CONCENTRATOR | 05/13/2004 |
| K132205 | INOVA LABS, INC. | ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM | 06/06/2014 |
| K113317 | INOVA LABS, INC. | LIFECHOICE OXYGEN CONCENTRATOR | 12/28/2011 |
| K141967 | INOVO, INC. | PUREFILL OXYGEN COMPRESSOR | 11/07/2014 |
| K072688 | INTERNATIONAL BIOPHYSICS CORP. | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | 01/11/2008 |
| K020386 | INVACARE CORP. | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | 07/02/2002 |
| K983777 | INVACARE CORP. | MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM | 12/18/1998 |
| K071928 | INVACARE CORP. | THE INVACARE FLYER, MODEL IPC 100 | 12/12/2007 |
| K003939 | INVACARE CORP. | VENTURE HOME FILL II, MODEL IOH 200 | 03/21/2001 |
| K021685 | INVACARE CORP. | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | 07/23/2002 |
| K983627 | INVACARE CORP. | VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM | 10/22/1999 |
| K191159 | Invacare Corporation | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentra | 08/29/2019 |
| K200890 | Invacare Corporation | Invacare Perfecto2V Oxygen Concentrator | 08/06/2020 |
| K203210 | Invacare Corporation | Invacare Platinum 5NXG Oxygen Concentrator | 04/12/2021 |
| K160630 | INVACARE CORPORATION | Invacare Platinum Mobile Oxygen Concentrator | 09/27/2016 |
| K083751 | INVACARE CORPORATION | INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 | 05/21/2009 |
| K223740 | Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | 10/05/2023 |
| K213825 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | 04/28/2023 |
| K083559 | JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. | YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B | 09/04/2009 |
| K081267 | KEDL INTERNATION LIMITED | HYGEIA-5 OXYGEN CONCENTRATOR | 09/23/2008 |
| K013223 | LITTON SYSTEMS, INC. | PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS) | 02/11/2002 |
| K131968 | LONGFIAN SCITECH CO., LTD. | LONGFIAN OXYGEN CONCENTRATOR | 09/05/2014 |
| K213210 | LONGFIAN SCITECH CO., LTD. | Oxygen Concentrator, Model JAY-5AW | 12/08/2022 |
| K080391 | MEDICAL DEPOT | DRIVE SOLSTICE OXYGEN CONCENTRATOR | 03/18/2008 |
| K954506 | MEDTRAK INTL., INC. | EMOX | 04/30/1996 |
| K050430 | MERITS HEALTH PRODUCTS CO., LTD. | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR | 08/04/2005 |
| K053229 | MERITS HEALTH PRODUCTS CO., LTD. | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | 03/23/2006 |
| K053230 | MERITS HEALTH PRODUCTS CO., LTD. | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | 05/16/2006 |
| K091716 | MERITS HEALTH PRODUCTS CO., LTD. | MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY | 04/02/2010 |
| K014301 | MERITS HEALTH PRODUCTS CO., LTD. | MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | 02/11/2002 |
| K011844 | MERITS HEALTH PRODUCTS., INC. | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | 08/28/2001 |
| K062153 | MOLECULAR PRODUCTS LTD. | PORTABLE OXYGEN GENERATOR SYSTEM | 11/21/2006 |
| K131016 | MOLECULAR PRODUCTS LTD. | ROGS | 11/27/2013 |
| K032509 | NIDEK MEDICAL PRODUCTS, INC. | MARK 5 NUVO (M5C5) | 03/18/2004 |
| K093308 | NIDEK MEDICAL PRODUCTS, INC. | MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD | 01/14/2010 |
| K082566 | NIDEK MEDICAL PRODUCTS, INC. | MARK 5 NUVO LITE OCSI AND STD | 12/03/2008 |
| K123738 | NIDEK MEDICAL PRODUCTS, INC. | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD | 02/28/2013 |
| K040892 | NIDEK MEDICAL PRODUCTS, INC. | MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 | 04/29/2004 |
| K192693 | Nidek Medical Products, Inc. | Nuvo Nano Portable Oxygen Concentrator | 05/07/2020 |
| K182454 | O2 Concepts LLC | O2 Concepts Oxlife Independence Model 301-0001 | 12/20/2018 |
| K020362 | ON SITE GAS SYSTEMS INC. | P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM | 02/12/2002 |
| K021082 | ON SITE GAS SYSTEMS, INC. | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 | 05/22/2002 |
| K014078 | ON SITE GAS SYSTEMS, INC. | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM | 01/08/2002 |
| K030920 | ON SITE GAS SYSTEMS, INC. | POGS 33 | 03/10/2004 |
| K063454 | ON SITE GAS SYSTEMS, INC. | POGS, MODEL 33C | 05/09/2007 |
| K092636 | ON SITE GAS SYSTEMS, INC. | POGS, MODEL 65/130 | 01/07/2010 |
| K041664 | ON SITE GAS SYSTEMS, INC. | PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C | 07/29/2004 |
| K033863 | OX-GEN INC. | OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 | 08/22/2005 |
| K060922 | OXLIFE LLC | OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5 | 05/30/2006 |
| K080082 | OXLIFE LLC | OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS | 04/16/2008 |
| K971964 | OXLIFE, INC. | OXLIFE EXCELL OXYGEN CONCENTRATORS | 08/15/1997 |
| K955549 | OXLIFE, INC. | OXLIFE OXYGEN CONCENTRATORS | 03/15/1996 |
| K162433 | OXUS, INC | GCE Zen-O Portable Oxygen Concentrator | 05/24/2017 |
| K211056 | Oxus, Inc. | Oxus Sieve Beds | 05/31/2023 |
| K052396 | OXYSURE SYSTEMS, INC. | OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 | 12/09/2005 |
| K043615 | OXYTEC MEDICAL CORPORATION | OXYTEC, MODEL 900 | 02/09/2005 |
| K020330 | PACIFIC CONSOLIDATED INDUSTRIES LLP | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS) | 04/12/2002 |
| K040738 | PACIFIC CONSOLIDATED INDUSTRIES LLP | MOBILE OXYGEN STORAGE TANK (MOST) | 04/30/2004 |
| K100957 | PACIFIC CONSOLIDATED INDUSTRIES, LLC | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION | 01/21/2011 |
| K061414 | PACIFIC CONSOLIDATED INDUSTRIES, LLC | EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD | 01/22/2007 |
| K120566 | PACIFIC PRECISION PRODUCTS | O2PAK OXYGEN GENERATOR | 07/24/2012 |
| K072348 | PRECISION MEDICAL, INC. | PRECISION OXYGEN CONCENTRATOR | 10/27/2008 |
| K103563 | PRECISION MEDICAL, INC. | PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 | 07/01/2011 |
| K993088 | PURITAN BENNETT CORP. | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI | 10/08/1999 |
| K190304 | Qingdao Kingon Medical Science and Technology Co. | Kingon P2 Oxygen Concentrator | 02/29/2020 |
| K223379 | Qingdao Kingon Medical Science and Technology Co., Ltd. | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | 06/22/2023 |
| K210371 | Qingdao Kingon Medical Science and Technology Co., Ltd. | Portable Oxygen Concentrator, model: P2-E6 | 06/03/2022 |
| K111885 | RESPIRONICS INC. | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | 11/04/2011 |
| K091191 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | GAS TRANSFILL | 10/23/2009 |
| K081206 | RESPIRONICS, INC. | HOMELOX | 07/28/2008 |
| K061261 | RESPIRONICS, INC. | L4 OXYGEN CONCENTRATOR | 06/28/2006 |
| K043006 | RESPIRONICS, INC. | MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 | 02/11/2005 |
| K091028 | RESPIRONICS, INC. | OMNI 5 TOTAL O2 DELIVERY SYSTEM | 07/23/2009 |
| K100920 | SEQUAL TECHNOLOGIES CO., LTD | MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES | 11/29/2010 |
| K091541 | SEQUAL TECHNOLOGIES CO., LTD | MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES | 12/31/2009 |
| K042262 | SEQUAL TECHNOLOGIES, INC. | INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 | 09/10/2004 |
| K003472 | SEQUAL TECHNOLOGIES, INC. | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM | 06/04/2001 |
| K083163 | SEQUAL TECHNOLOGIES, INC. | OMNI 2 OXYGEN SYSTEM | 10/20/2009 |
| K013931 | SEQUAL TECHNOLOGIES, INC. | OMNI OXYGEN SYSTEM, MODEL 1000 | 03/27/2002 |
| K081508 | SHENYANG CANTA MEDICAL TECH CO., LTD. | HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN | 08/27/2008 |
| K971947 | SIM ITALIA S.R.L. | INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) | 10/03/1997 |
| K963042 | SIM ITALIA S.R.L. | INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 | 11/01/1996 |
| K030233 | SIM ITALIA S.R.L. | TRAVELSOME STANDARD | 04/25/2003 |
| K952941 | SUN MEDICAL EQUIPMENT, INC. | SUN MODEL OA 3000 OXYGEN ANALYZER | 01/29/1996 |
| K071397 | SUNRISE MEDICAL | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES | 10/01/2007 |
| K053240 | SUNRISE MEDICAL | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES | 02/03/2006 |
| K081468 | SUNRISE MEDICAL | DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES | 08/25/2008 |
| K991722 | SUNRISE MEDICAL HHG, INC. | DEVILBISS 5 LITER OXYGEN CONCENTRATOR | 11/03/1999 |
| K091650 | SWR INTERNATIONAL, LTD | AXS-590 SERIES | 11/24/2009 |
| K172234 | SysMed (China) Co., Ltd | Oxygen Concentrator | 06/01/2018 |
| K981078 | TRANSTRACHEAL SYSTEMS | TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 | 07/23/1998 |
| K134023 | ULTRA ELECTRONICS LIMITED PRECISION AIR & LAND SY | 2300 SERIES MGO PORTABLE OXYGEN | 04/25/2014 |
| K121260 | VBOX, INC. | TROOPER OXYGEN CONCENTRATOR | 09/21/2012 |
| K033405 | ZHEJIANG LONGFEI INDUSTRIAL CO., LTD. | LONGFEI LFY-I-5 OXYGEN CONCENTRATOR | 10/18/2005 |
| K222920 | Zhengzhou Olive Electronic Technology Co., Ltd. | Oxygen concentrator | 07/20/2023 |
| K121531 | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. | A&J 5L POCA SERIES OXYGEN CONCENTRATOR | 07/17/2012 |
| K071608 | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. | A&J POCA01 OXYGEN CONCENTRATOR | 01/11/2008 |
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