Generator, Oxygen, Portable

FDA product code CAW · Class II (moderate risk) · 21 CFR 868.5440 · Anesthesiology

288510(k) clearances
0PMA approvals
41recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional BMC Medical Co., Ltd.08/14/2026SE
K252399Portable Oxygen ConcentratorCAW · Traditional Honsun (Nantong) Co., Ltd.06/17/2026SE
K252965Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional Oxytek Medical Technology Co., Ltd.05/29/2026SE
K252407OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional Mv Life, LLC04/23/2026SE
K253549DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional Devilbiss Healthcare, LLC03/26/2026SE
K251534Oxygen Concentrator (J10A)CAW · Traditional Foshan Kycare Medical Equipment Co., Ltd.12/29/2025SE
K252616Portable oxygen concentrator (JLO-190P)CAW · Traditional Shenzhen Homed Medical Device Co., Ltd.12/22/2025SE
K251764Oxygen Concentrator-P2-O5ECAW · Traditional Qingdao Kingon Medical Science and Technology…12/22/2025SE
K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional Shenzhen Harveymed Technology Co., Ltd.12/16/2025SE
K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional Devilbiss Healthcare, LLC12/09/2025SE
K251607Oxygen Concentrator (J5A)CAW · Traditional Foshan Kycare Medical Equipment Co., Ltd.11/21/2025SE
K243833Portable oxygen concentrator (JAY-1000P)CAW · Traditional Longfian Scitech Co., Ltd.09/29/2025SE
K250625Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable…CAW · Traditional Nanjing Yinuoji Medical Technology Co., Ltd.08/27/2025SE
K251130Portable Oxygen Concentrator (JM-P50A)CAW · Traditional Jiangsu Jumao X-Care Medical Equipment Co., Ltd.08/21/2025SE
K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)CAW · Traditional Caire, Inc.07/11/2025SE
K242736Portable Oxygen Concentrator (Spirit-3)CAW · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.06/05/2025SE
K242718Portable Oxygen Concentrator (P2-TOC)CAW · Traditional Qingdao Kingon Medical Science and Technology…02/28/2025SE
K240840Oxygen Concentrator (ZY-10AB/115)CAW · Traditional Foshan Care Medical Technology Co., Ltd.12/06/2024SE
K240561Rugged Oxygen Generator (ROG) (RO01-00001)CAW · Traditional Molecular Products , Ltd.12/06/2024SE
K230969Oxygen ConcentratorCAW · Traditional Jiangsu Jumao X-Care Medical Equipment Co., Ltd.11/09/2023SE
K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)CAW · Traditional Qingdao Kingon Medical Science and Technology…10/18/2023SE
K223740Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)CAW · Traditional Jiangsu Konsung Bio-Medical Science and…10/05/2023SE
K222920Oxygen concentratorCAW · Traditional Zhengzhou Olive Electronic Technology Co., Ltd.07/20/2023SE
K230052Inogen Rove 6CAW · Traditional Inogen, Inc.06/30/2023SE
K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)CAW · Traditional Qingdao Kingon Medical Science and Technology…06/22/2023SE
K211056Oxus Sieve BedsCAW · Traditional Oxus, Inc.05/31/2023SE
K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5ACAW · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.04/28/2023SE
K222086Inogen Rove 4 Portable Oxygen ConcentratorCAW · Traditional Inogen12/09/2022SE
K213210Oxygen Concentrator, Model JAY-5AWCAW · Traditional Longfian Scitech Co., Ltd.12/08/2022SE
K210371Portable Oxygen Concentrator, model: P2-E6CAW · Traditional Qingdao Kingon Medical Science and Technology…06/03/2022SE
K202389Oxygen ConcentratorCAW · Traditional Foshan Mic Medical Technology Co., Ltd.04/08/2022SE
K203210Invacare Platinum 5NXG Oxygen ConcentratorCAW · Traditional Invacare Corporation04/12/2021SE
K203086X-PLO2RCAW · Traditional Belluscura, LLC03/02/2021SE
K200890Invacare Perfecto2V Oxygen ConcentratorCAW · Traditional Invacare Corporation08/06/2020SE
K200496Aer XCAW · Special 3B Medical, Inc.07/24/2020SE
K191875Owgels Oxygen ConcentratorCAW · Traditional Guangzhou Life Light Electronic Technology Co.…07/20/2020SE
K192693Nuvo Nano Portable Oxygen ConcentratorCAW · Traditional Nidek Medical Products, Inc.05/07/2020SE
K190304Kingon P2 Oxygen ConcentratorCAW · Traditional Qingdao Kingon Medical Science and Technology Co.02/29/2020SE
K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder…CAW · Traditional Invacare Corporation08/29/2019SE
K180837CONTEC Oxygen ConcentratorCAW · Traditional Contec Medical System Co., Ltd.01/10/2019SE
K182454O2 Concepts Oxlife Independence Model 301-0001CAW · Traditional O2 Concepts, LLC12/20/2018SE
K172234Oxygen ConcentratorCAW · Traditional Sysmed (China) Co., Ltd.06/01/2018SE
K172648Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorCAW · Traditional Devilbiss Healthcare, LLC03/23/2018SE
K162433GCE Zen-O Portable Oxygen ConcentratorCAW · Traditional Oxus, Inc.05/24/2017SE
K160630Invacare Platinum Mobile Oxygen ConcentratorCAW · Traditional Invacare Corporation09/27/2016SE
K150930Deployable Oxygen Generation System-Smaill (DOGS-S)CAW · Traditional Airsep Corporation12/18/2015SE
K141967Purefill Oxygen CompressorCAW · Traditional Inovo, Inc.11/07/2014SE
K131968Longfian Oxygen ConcentratorCAW · Traditional Longfian Scitech Co., Ltd.09/05/2014SE
K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)CAW · Traditional Inogen, Inc.06/20/2014SE
K132205Actovox DUO2 Oxygen Concentrator SystemCAW · Traditional Inova Labs, Inc.06/06/2014SE
K1340232300 Series Mgo Portable OxygenCAW · Traditional Ultra Electronics Limited Precision Air & Land SY04/25/2014SE
K131990Oxygen Generator Liquefier - (Ogl)CAW · Traditional Essex Cryogenics of Missouri, Inc.02/21/2014SE
K131016RogsCAW · Special Molecular Products , Ltd.11/27/2013SE
K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDCAW · Special Nidek Medical Products, Inc.02/28/2013SE
K120785Omni 3 Oxygen SystemCAW · Special Caire, Inc.10/25/2012SE
K121260Trooper Oxygen ConcentratorCAW · Traditional Vbox, Inc.09/21/2012SE
K120566O2PAK Oxygen GeneratorCAW · Traditional Pacific Precision Products07/24/2012SE
K121531A&J 5L Poca Series Oxygen ConcentratorCAW · Traditional Zhongshan A&J Medical Equipment Co., Ltd.07/17/2012SE
K121167Caire Companion 5 Oxygen ConcentratorCAW · Traditional Caire, Inc.05/02/2012SE
K113317Lifechoice Oxygen ConcentratorCAW · Special Inova Labs, Inc.12/28/2011SE
K111885Simplygo Portable Oxygen ConcentratorCAW · Special Respironics, Inc.11/04/2011SE
K103563Precision Portable Oxygen Concentration Model 4150CAW · Traditional Precision Medical, Inc.07/01/2011SE
K101154Centrox, Reliant, Ultrox, As-D+, As-E, As-G, As-J, As-K and As-LCAW · Traditional Airsep Corp.03/28/2011SE
K102750O2-IN-A-BOX, O2-IN-A-BOXCAW · Traditional Geto2, Inc.02/11/2011SE
K100957Deployable Oxygen Concentration System (Docs), Model 66, Deployable Oxygen CeoncentrationCAW · Traditional Pacific Consolidated Industries, LLC01/21/2011SE
K100920Mesa II Oxygen Concentrator Model: T2000 SeriesCAW · Abbreviated Sequal Technologies Co., Ltd.11/29/2010SE
K102245Care ZY5BA Oxygen ConcentratorCAW · Traditional Foshan Care Medical Technology Co., Ltd.11/09/2010SE
K091716Merits Health Products Profil Q601 Series Oxygen Filling AccessoryCAW · Special Merits Health Products Co., Ltd.04/02/2010SE
K093308Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STDCAW · Special Nidek Medical Products, Inc.01/14/2010SE
K092636Pogs, Model 65/130CAW · Traditional On Site Gas Systems, Inc.01/07/2010SE
K091541Mesa Oxygen Concentrator, Model 2-6000 SeriesCAW · Abbreviated Sequal Technologies Co., Ltd.12/31/2009SE
K091650AXS-590 SeriesCAW · Traditional Swr International, Ltd.11/24/2009SE
K091191Gas TransfillCAW · Traditional Respironics Inc., Sleep & Home Respiratory Group10/23/2009SE
K083163Omni 2 Oxygen SystemCAW · Traditional Sequal Technologies, Inc.10/20/2009SE
K083559Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7F-5BCAW · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.09/04/2009SE
K090007Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000CAW · Traditional Danyang Jumao Healthcare Equipment Co., Ltd.07/24/2009SE
K091028Omni 5 Total O2 Delivery SystemCAW · Special Respironics, Inc.07/23/2009SE
K083751Invacare Tpoc Portable Concentrator, Model TPOC100CAW · Traditional Invacare Corporation05/21/2009SE
K082566Mark 5 Nuvo Lite Ocsi and STDCAW · Abbreviated Nidek Medical Products, Inc.12/03/2008SE
K072348Precision Oxygen ConcentratorCAW · Abbreviated Precision Medical, Inc.10/27/2008SE
K081267HYGEIA-5 Oxygen ConcentratorCAW · Traditional Kedl Internation Limited09/23/2008SE
K081508HG Oxygen Concentrator, Models HG5-W & HG5-WNCAW · Traditional Shenyang Canta Medical Tech. Co., Ltd.08/27/2008SE
K081468Devilbiss Portable Oxygen Concentrator, 306 SeriesCAW · Traditional Sunrise Medical08/25/2008SE
K081206HomeloxCAW · Traditional Respironics, Inc.07/28/2008SE
K080082Oxlife Independence Oxygen ConcentratorsCAW · Traditional Oxlife, LLC04/16/2008SE
K080391Drive Solstice Oxygen ConcentratorCAW · Traditional Medical Depot03/18/2008SE
K072688Lifechoice Oxygen Concentrator, Model OXY1000CAW · Abbreviated International Biophysics Corp.01/11/2008SE
K071608A&J POCA01 Oxygen ConcentratorCAW · Traditional Zhongshan A&J Medical Equipment Co., Ltd.01/11/2008SE
K073242Portable Oxygen Concentrator, Model RS-00400CAW · Traditional Delphi Medical Systems01/03/2008SE
K071928The Invacare Flyer, Model Ipc 100CAW · Traditional Invacare Corp.12/12/2007SE
K071904Deployable Oxygen Generation System - Medium (Dogs-M)CAW · Traditional Carleton Life Support Systems, Inc.10/25/2007SE
K071397Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesCAW · Special Sunrise Medical10/01/2007SE
K071461Model 300D Home Oxygen LiquefierCAW · Traditional Copd Partners, Inc.08/21/2007SE
K063454Pogs, Model 33CCAW · Traditional On Site Gas Systems, Inc.05/09/2007SE
K061414Expeditionary Delployable Oxygen Concentration System (Edocs), Models 120B and 30;MOBILE…CAW · Traditional Pacific Consolidated Industries, LLC01/22/2007SE
K062153Portable Oxygen Generator SystemCAW · Traditional Molecular Products , Ltd.11/21/2006SE
K061261L4 Oxygen ConcentratorCAW · Special Respironics, Inc.06/28/2006SE
K060922Oxlife Freedom Five Oxygen Concentrators, Model KXF5CAW · Special Oxlife, LLC05/30/2006SE
K053230Merits Health Products Oxygen ConcentratorsCAW · Traditional Merits Health Products Co., Ltd.05/16/2006SE
K053229Merits Health Products Oxygen ConcentratorsCAW · Special Merits Health Products Co., Ltd.03/23/2006SE
K053240Devilbiss Oxygen Cylinder Filling System, 535 SeriesCAW · Traditional Sunrise Medical02/03/2006SE
K052396Oxysure Portable Oxygen Generator, Model 615CAW · Traditional Oxysure Systems, Inc.12/09/2005SE
K043520Emg CTA01-XXX Series Puro Oxygen ConcentratorCAW · Abbreviated Emg Technology Co., Ltd.10/21/2005SE
K033405Longfei LFY-I-5 Oxygen ConcentratorCAW · Traditional Zhejiang Longfei Industrial Co., Ltd.10/18/2005SE
K051887Patient Ventilation Oxygen Concentrating System, High Flow (Pvocs HF)CAW · Traditional Carleton Life Support Systems, Inc.09/27/2005SE
K033863Ox-Gen Flexible O2 Generation System, Model 6-OX-03CAW · Traditional Ox-Gen, Inc.08/22/2005SE
K050430Merits Health Products Oxygen ConcentratorCAW · Traditional Merits Health Products Co., Ltd.08/04/2005SE
K042944Home-Away System, Model 1041CAW · Traditional In-X Corporation04/15/2005SE
K043006Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605CAW · Abbreviated Respironics, Inc.02/11/2005SE
K043615Oxytec, Model 900CAW · Traditional Oxytec Medical Corporation02/09/2005SE
K042262Integra Oxygen Concentrator, Model 6323A-OM-10CAW · Special Sequal Technologies, Inc.09/10/2004SE
K041664Portable Oxygen Generation System: Pogs 33CCAW · Traditional On Site Gas Systems, Inc.07/29/2004SE
K032818Inogen One Oxygen ConcentratorCAW · Traditional Inogen, Inc.05/13/2004SE
K040738Mobile Oxygen Storage Tank (Most)CAW · Traditional Pacific Consolidated Industries Llp04/30/2004SE
K040892Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905CAW · Special Nidek Medical Products, Inc.04/29/2004SE
K032509Mark 5 Nuvo (M5C5)CAW · Traditional Nidek Medical Products, Inc.03/18/2004SE
K030920Pogs 33CAW · Traditional On Site Gas Systems, Inc.03/10/2004SE
K030233Travelsome StandardCAW · Special Sim Italia S.R.L.04/25/2003SE
K022684Portable Therapeutic Oxygen Concentration System (Ptocs)CAW · Abbreviated Essex Cryogenics of Missouri, Inc.09/11/2002SE
K021685Venture Homefill II with Oxygen ConserverCAW · Traditional Invacare Corp.07/23/2002SE
K020386Invacare Platinum, Models Irc 5LX and Irc 5LX02CAW · Traditional Invacare Corp.07/02/2002SE
K021082On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0CAW · Traditional On Site Gas Systems, Inc.05/22/2002SE
K020330Deployable Oxygen Concentration System (Docs)CAW · Abbreviated Pacific Consolidated Industries Llp04/12/2002SE
K013931Omni Oxygen System, Model 1000CAW · Traditional Sequal Technologies, Inc.03/27/2002SE
K020324Lifestyle Oxygen ConcentratorCAW · Traditional Airsep Corp.03/13/2002SE
K020362P.O.G.S. 3.3 Portable Oxygen Generator SystemCAW · Traditional On Site Gas Systems, Inc.02/12/2002SE
K014301Modification to Merits Health Products Oxygen ConcentratorsCAW · Special Merits Health Products Co., Ltd.02/11/2002SE
K013223Patient Ventilation Oxygen Concentrating System (Pvocs)CAW · Traditional Litton Systems, Inc.02/11/2002SE
K012037Healthlife Oxygen Concentrator Model AS009CAW · Traditional Airsep Corp.01/17/2002SE
K014078On Site Gas Systems Portable Oxygen Generator SystemCAW · Traditional On Site Gas Systems, Inc.01/08/2002SE
K004047Home-Away SystemCAW · Traditional In-X Corp.12/18/2001SE
K013472Total O2CAW · Traditional Chad Therapeutics, Inc.11/28/2001SE
K011844Merits Health Products Oxygen ConcentratorsCAW · Traditional Merits Health Products., Inc.08/28/2001SE
K003472Integra Oxygen Concentrators Model 6400-OMCAW · Traditional Sequal Technologies, Inc.06/04/2001SE
K003939Venture Home Fill II, Model Ioh 200CAW · Traditional Invacare Corp.03/21/2001SE
K991722Devilbiss 5 Liter Oxygen ConcentratorCAW · Traditional Sunrise Medical Hhg, Inc.11/03/1999SE
K983627Venture Iho 100 Home Fill Complete Home Oxygen SystemCAW · Traditional Invacare Corp.10/22/1999SE
K993088Puritan-Bennett Aeris 590 Oxygen Concentrator with OciCAW · Special Puritan Bennett Corp.10/08/1999SE
K981047Fresh AirCAW · Traditional Colorado Medtech, Inc.09/16/1999SE
K991569Home/Commercial Oxygen Unit by System O2CAW · Traditional 02 Marketing Group, Inc.08/03/1999SE
K984081EmoxCAW · Traditional Emox 911 CC03/17/1999SE
K983777Modification to Venture Iho 100 Complete Home Oxygen SystemCAW · Traditional Invacare Corp.12/18/1998SE
K982243Canogen Portable Oxygen Generator Model 615CAW · Traditional Canogen International , Ltd.11/19/1998SE
K981078Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000CAW · Traditional Transtracheal Systems07/23/1998SE
K972614Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/Opi Model 605CAW · Traditional Healthdyne Technologies, Inc.01/20/1998SE
K971889Chad Total O2 Delivery SystemCAW · Traditional Chad Therapeutics, Inc.11/17/1997SE
K971947Innosan Travelair S Plus Portable Oxygen Concentrator, Code No. M407001853 (with Ac…CAW · Traditional Sim Italia S.R.L.10/03/1997SE
K971964Oxlife Excell Oxygen ConcentratorsCAW · Traditional Oxlife, Inc.08/15/1997SE
K971129Oxypure Portable Oxygen GeneratorCAW · Traditional Arbor Research Corp.06/24/1997SE
K960309Airsep Newlife Dual Six Oxygen Concentrator (Modification)CAW · Traditional Airsep Corp.02/28/1997SE
K963042Innosan Travelair S Portable Oxygen Concentrator, Code No. M407001853CAW · Traditional Sim Italia S.R.L.11/01/1996SE
K954506EmoxCAW · Traditional Medtrak Intl., Inc.04/30/1996SE
K955549Oxlife Oxygen ConcentratorsCAW · Traditional Oxlife, Inc.03/15/1996SE
K952941Sun Model Oa 3000 Oxygen AnalyzerCAW · Traditional Sun Medical Equipment, Inc.01/29/1996SE
K954271Westmed Condesate Collection TrapCAW · Traditional Westmed Intl.12/28/1995SE
K9538155 LPM Oxygen ConcentratorCAW · Traditional Devilbiss Health Care, Inc.11/09/1995SE
K953949Humidifier & AccessoriesCAW · Traditional Fisher & Paykel Electronics , Ltd.10/16/1995SE
K951882Eco Check (Ecovalve and Oxygen Monitor)CAW · Traditional Airsep Corp.10/16/1995SE
K941145Oxy-GeneratorCAW · Traditional Med Systems09/27/1995SE
K9520373 LPM Oxygen ConcentratorCAW · Traditional Devilbiss Health Care, Inc.09/06/1995SE
K952268Model Delta, Om Oxygen ConcentratorCAW · Traditional Caire, Inc.08/11/1995SE
K942082Model 6323 Oxygen ConcentratorCAW · Traditional Dynotec Corp.12/08/1994SE
K933081Oxlife Oxygen ConcentratorCAW · Traditional Oxlife, Inc.11/01/1994SE
K924565SBS Model 1615CAW · Traditional Stand-By-Systems, Inc.09/09/1994SE
K935370Miniox Ia Oxygen AnalyzerCAW · Traditional Minesafety Appliances Co.08/02/1994SE
K942357H-500 Alliance Oxygen ConcentratorCAW · Traditional Healthdyne, Inc.05/27/1994SE
K931355Whisper O2CAW · Traditional Trilogic Corp.03/25/1994SE
K924818Mobilaire V & III PRO2 Oxygen Sensors FeaturesCAW · Traditional Invacare Corp.08/06/1993SE
K924152Keystone Concentrator, Model PV5LCAW · Traditional Devilbiss Health Care, Inc.06/07/1993SE
K924100Oxygen ConcentratorCAW · Traditional Allied Healthcare Products, Inc.03/19/1993SE
K923650ScottyCAW · Traditional Mountain Medical Equipment, Inc.01/15/1993SE
K924146OH-500 Oxygen ConcentratorCAW · Traditional Healthdyne, Inc.01/07/1993SE
K914916Alpine VCAW · Traditional Mountain Medical Equipment, Inc.09/23/1992SE
K914488Models: IRCRF5, IRCPF16 Flowmeter Accessory KitsCAW · Traditional Invacare Corp.09/15/1992SE
K915381Portable Oxygen GeneratorCAW · Traditional Aequitron Medical, Inc.03/11/1992SE
K912794Economate/PatriotCAW · Traditional Foothills Medical Equipment, Inc.02/21/1992SE
K913327CONTEMPRO2 Home Health Care RegulatorCAW · Traditional Continental Products, Inc.12/20/1991SE
K904639Genox Model CT-1CAW · Traditional Pacific Consolidated Industries08/13/1991SE
K901712Guild Maxox Generator (Maxox)CAW · Traditional Guild Assoc., Inc.02/27/1991SE
K904087Mobilaire III and V Model Irc 301 and 501 Oxy. ConCAW · Traditional Invacare Corp.10/26/1990SE
K904271OxlifeCAW · Traditional Medical Repair Service, Inc.10/12/1990SE
K903608V-LinkCAW · Traditional GE Medical Systems10/12/1990SE
K904002Genox Model CT-1 Oxygen/Nitrogen Gener-Distr SystCAW · Traditional Pacific Consolidated Industries09/05/1990SE
K903411Field Medical Oxygen Gen/Dist Sys-Battlefield PurpCAW · Traditional Guild Assoc., Inc.08/31/1990SE
K902890Aspen 3 Oxygen ConcentratorCAW · Traditional Mountain Medical Equipment, Inc.07/19/1990SE
K896457Devilbiss Model PV02 SeriesCAW · Traditional Devilbiss Health Care, Inc.02/01/1990SE
K895177Puritan-Bennett Oxygen Concentration IndicatorCAW · Traditional Puritan Bennett Corp.11/21/1989SE
K895141Model 590 Oxygen ConcentratorCAW · Traditional Puritan Bennett Corp.10/31/1989SE
K894384K.E.E. Oxygen ConcentratorCAW · Traditional Kee Medical Services, Inc.10/27/1989SE
K891488Mobilaire V Oxygen ConcentratorCAW · Traditional Invacare Corp.05/25/1989SE
K884563Oxygen Concentrator W/Concentration 3LPM 93% +/-3%CAW · Traditional Ivex Medical, Inc.04/26/1989SE
K884018Lamelli Oxygen Enriched Environment System & TentCAW · Traditional Lamelli Pulmonary Research Center02/27/1989SE
K890150H-3000 Oxygen ConcentratorCAW · Traditional Healthdyne, Inc.01/31/1989SE
K884581Reliant Oxygen ConcentratorCAW · Traditional Airsep Corp.01/11/1989SE
K883837Mikado Ac 405CAW · Traditional Ivex Medical, Inc.12/12/1988SE
K884084Portable Oxygen GeneratorCAW · Traditional Mountain Medical Equipment, Inc.11/21/1988SE
K883591MARK-5 ConcentratorCAW · Traditional Nidek Medical Products, Inc.11/02/1988SE
K881802Alpine Portable Oxygen GeneratorCAW · Traditional Mountain Medical Equipment, Inc.07/08/1988SE
K880044Oeco Membrane Oxygne & Vapor Enricher Model OE-8CAW · Traditional Oxygen Enrichment Company, Ltd.03/28/1988SE
K873526Pall Field Medical Oxygen Genera. & Distri. SystemCAW · Traditional Pall Safety Atmospheres, Inc.02/29/1988SE

Recalls

RecallProductFirmInitiated
Z-1815-2026 Class IIReact Health PHOENIX 5L Oxygen ConcentratorDevices which did not meet internal quality specifications were inadvertently distributed. 3B Medical, Inc.02/04/2026Open, Classified
Z-0481-2026 Class IISimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits…Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the… Philips Respironics, Inc.10/07/2025Open, Classified
Z-1980-2025 Class IIGCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-SErroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually… Ohio Medical Corporation05/08/2025Open, Classified
Z-1727-2025 Class IiGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power…Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. Medical Depot Inc.04/11/2025Open, Classified
Z-0795-2025 Class IJMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5LOxygen concentrator may melt or catch on fire during use. Jiangsu Jumao X-Care Medical Equipment Co Ltd12/09/2024Open, Classified
Z-0481-2025 Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.Potential failure of affected units to recharge the battery of the oxygen concentrators. Caire, Inc.10/04/2024Completed
Z-0480-2025 Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.Potential failure of affected units to recharge the battery of the oxygen concentrators. Caire, Inc.10/04/2024Completed
Z-0479-2025 Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Potential failure of affected units to recharge the battery of the oxygen concentrators. Caire, Inc.10/04/2024Completed
Z-0478-2025 Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Potential failure of affected units to recharge the battery of the oxygen concentrators. Caire, Inc.10/04/2024Completed
Z-1558-2023 Class IIDEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK…The instruction manual is being replaced with an updated version that is in alignment with labeling… DeVilbiss Healthcare LLC03/09/2023Open, Classified
Z-0724-2023 Class IIDeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-QThe firm has received complaints of the device becoming hot. The firm has updated the user manual to include… DeVilbiss Healthcare LLC11/18/2022Open, Classified
Z-0229-2023 Class II125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of…An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas… DeVilbiss Healthcare LLC09/19/2022Open, Classified
Z-1369-2022 Class IIIInvacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada…Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx… Invacare Corporation06/10/2022Open, Classified
Z-1117-2022 Class IICAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and…The device was not cleared for U.S. distribution. Caire, Inc.03/25/2022Terminated
Z-0514-2021 Class IIInvacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory…Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.)… Invacare Corporation10/30/2020Terminated
Z-0805-2020 Class IICAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle…Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in… Caire, Inc.11/21/2019Terminated
Z-0248-2020 Class IISAROS Oxygen System Model 3000There is an electronics control issue that causes the unit to not power on with battery power only. Caire, Inc.09/16/2019Terminated
Z-0407-2018 Class IIPURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000SPost-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an… Inovo, Inc10/09/2017Terminated
Z-0760-2017 Class IIINOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can…Device can fail during operation. Inovo, Inc07/21/2016Terminated
Z-2253-2015 Class IIOxySure Model 615 disposable replacement cartridges, for portable oxygen generator.Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for… Oxysure Systems, Inc.06/12/2015Terminated
Z-0872-2015 Class IIComponent- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per…The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. Invacare Corporation10/31/2014Terminated
Z-0577-2015 Class IIInvacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single…It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to… Invacare Corporation09/23/2014Terminated
Z-0647-2014 Class IIOn Site Gas Systems POGS 33C Portable Oxygen Generation SystemHeat exchanger hose becomes weak and may fail. On Site Gas Systems Inc.12/19/2013Terminated
Z-0768-2013 Class IILi-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also…Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was… Oxus America, Inc.01/14/2013Terminated
Z-1782-2012 Class INIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1781-2012 Class INIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1780-2012 Class INIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1779-2012 Class INIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1778-2012 Class INIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1777-2012 Class INIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1776-2012 Class INIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1775-2012 Class INIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1774-2012 Class INIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Nidek Medical Products Inc05/01/2012Terminated
Z-1423-2011 HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows:…Invacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance… Invacare Corporation01/11/2011Terminated
Z-0567-2010 SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the…Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the… Sequal Technologies Inc10/01/2009Terminated
Z-2009-2009 Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator…The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the… Carleton Life Support Systems Inc07/24/2009Terminated
Z-0617-2009 DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow…potential for sieve beds to have been incorrectly assembled Sunrise Medical10/30/2008Terminated
Z-1474-2008 Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator…Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to… Medline Industries Inc03/04/2008Terminated
Z-1473-2008 Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator…Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to… Medline Industries Inc03/04/2008Terminated
Z-2201-2008 Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number:…The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had… Pacific Consolidated Industries LLC09/08/2007Terminated
Z-0038-2007 DeVilbiss iFill Personal Oxygen Station model number 535D.Potential for oxygen cylinders to not fill completely Sunrise Medical08/24/2006Terminated