Product Code: CAW FDA class 2 21 CFR 868.5440

Generator, Oxygen, Portable

Anesthesiology

The Portable Oxygen Generator is an anesthesiology device designed to produce oxygen on-demand for use in portable or emergency settings, supplying supplemental oxygen to patients who cannot access traditional compressed gas cylinders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CAW, regulated under 21 CFR 868.5440, within the Anesthesiology medical specialty. This device is eligible for third-party review.

View on FDA

510(k)s

287

FEI Numbers

Registration Numbers

Unique Applicants

151

Years Active

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Basic Information

Product Code: CAW
Device Class: FDA class 2
Regulation Number: 868.5440
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 287 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252399	Portable Oxygen Concentrator	Jun 17, 2026	Substantially Equivalent	Honsun (Nantong) Co., Ltd.
K252965	Oxygen Concentrator (OX-5A, OX-5C)	May 29, 2026	Substantially Equivalent	Oxytek Medical Technology Co., Ltd.
K252407	OxyGo Portable Oxygen Concentrator (1400-7000)	Apr 23, 2026	Substantially Equivalent	Mv Life, LLC
K253549	DeVilbiss 5 Liter Oxygen Concentrator (555)	Mar 26, 2026	Substantially Equivalent	Devilbiss Healthcare, LLC
K251534	Oxygen Concentrator (J10A)	Dec 29, 2025	Substantially Equivalent	Foshan Kycare Medical Equipment Co., Ltd.
K252616	Portable oxygen concentrator (JLO-190P)	Dec 22, 2025	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.
K251764	Oxygen Concentrator-P2-O5E	Dec 22, 2025	Substantially Equivalent	Qingdao Kingon Medical Science and Technology Co., Ltd.
K252268	V series portable oxygen concentrator (V5, V5C, V6, V6C)	Dec 16, 2025	Substantially Equivalent	Shenzhen Harveymed Technology Co., Ltd.
K250805	DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)	Dec 09, 2025	Substantially Equivalent	Devilbiss Healthcare, LLC
K251607	Oxygen Concentrator (J5A)	Nov 21, 2025	Substantially Equivalent	Foshan Kycare Medical Equipment Co., Ltd.
K243833	Portable oxygen concentrator (JAY-1000P)	Sep 29, 2025	Substantially Equivalent	Longfian Scitech Co., Ltd.
K250625	Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))	Aug 27, 2025	Substantially Equivalent	Nanjing Yinuoji Medical Technology Co., Ltd.
K251130	Portable Oxygen Concentrator (JM-P50A)	Aug 21, 2025	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
K250671	FreeStyle Comfort (AS200 / FreeStyle Comfort)	Jul 11, 2025	Substantially Equivalent	Caire, Inc.
K242736	Portable Oxygen Concentrator (Spirit-3)	Jun 05, 2025	Substantially Equivalent	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
K242718	Portable Oxygen Concentrator (P2-TOC)	Feb 28, 2025	Substantially Equivalent	Qingdao Kingon Medical Science and Technology Co., Ltd.
K240840	Oxygen Concentrator (ZY-10AB/115)	Dec 06, 2024	Substantially Equivalent	Foshan Care Medical Technology Co., Ltd.
K240561	Rugged Oxygen Generator (ROG) (RO01-00001)	Dec 06, 2024	Substantially Equivalent	Molecular Products , Ltd.
K230969	Oxygen Concentrator	Nov 09, 2023	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
K230702	Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)	Oct 18, 2023	Substantially Equivalent	Qingdao Kingon Medical Science and Technology Co., Ltd.
K223740	Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)	Oct 05, 2023	Substantially Equivalent	Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.
K222920	Oxygen concentrator	Jul 20, 2023	Substantially Equivalent	Zhengzhou Olive Electronic Technology Co., Ltd.
K230052	Inogen Rove 6	Jun 30, 2023	Substantially Equivalent	Inogen, Inc.
K223379	Portable Oxygen Concentrator (Model: P2-E7, P2-E)	Jun 22, 2023	Substantially Equivalent	Qingdao Kingon Medical Science and Technology Co., Ltd.
K211056	Oxus Sieve Beds	May 31, 2023	Substantially Equivalent	Oxus, Inc.
K213825	Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A	Apr 28, 2023	Substantially Equivalent	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
K222086	Inogen Rove 4 Portable Oxygen Concentrator	Dec 09, 2022	Substantially Equivalent	Inogen
K213210	Oxygen Concentrator, Model JAY-5AW	Dec 08, 2022	Substantially Equivalent	Longfian Scitech Co., Ltd.
K210371	Portable Oxygen Concentrator, model: P2-E6	Jun 03, 2022	Substantially Equivalent	Qingdao Kingon Medical Science and Technology Co., Ltd.
K202389	Oxygen Concentrator	Apr 08, 2022	Substantially Equivalent	Foshan Mic Medical Technology Co., Ltd.
K203210	Invacare Platinum 5NXG Oxygen Concentrator	Apr 12, 2021	Substantially Equivalent	Invacare Corporation
K203086	X-PLO2R	Mar 02, 2021	Substantially Equivalent	Belluscura, LLC
K200890	Invacare Perfecto2V Oxygen Concentrator	Aug 06, 2020	Substantially Equivalent	Invacare Corporation
K200496	Aer X	Jul 24, 2020	Substantially Equivalent	3B Medical, Inc.
K191875	Owgels Oxygen Concentrator	Jul 20, 2020	Substantially Equivalent	Guangzhou Life Light Electronic Technology Co., Ltd.
K192693	Nuvo Nano Portable Oxygen Concentrator	May 07, 2020	Substantially Equivalent	Nidek Medical Products, Inc.
K190304	Kingon P2 Oxygen Concentrator	Feb 29, 2020	Substantially Equivalent	Qingdao Kingon Medical Science and Technology Co.
K191159	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 Concentrator with Connectivity	Aug 29, 2019	Substantially Equivalent	Invacare Corporation
K180837	CONTEC Oxygen Concentrator	Jan 10, 2019	Substantially Equivalent	Contec Medical System Co., Ltd.
K182454	O2 Concepts Oxlife Independence Model 301-0001	Dec 20, 2018	Substantially Equivalent	O2 Concepts, LLC
K172234	Oxygen Concentrator	Jun 01, 2018	Substantially Equivalent	Sysmed (China) Co., Ltd.
K172648	Drive DeVilbiss iGo 2 Portable Oxygen Concentrator	Mar 23, 2018	Substantially Equivalent	Devilbiss Healthcare, LLC
K162433	GCE Zen-O Portable Oxygen Concentrator	May 24, 2017	Substantially Equivalent	Oxus, Inc.
K160630	Invacare Platinum Mobile Oxygen Concentrator	Sep 27, 2016	Substantially Equivalent	Invacare Corporation
K150930	Deployable Oxygen Generation System-Smaill (DOGS-S)	Dec 18, 2015	Substantially Equivalent	Airsep Corporation
K141967	PUREFILL OXYGEN COMPRESSOR	Nov 07, 2014	Substantially Equivalent	Inovo, Inc.
K131968	LONGFIAN OXYGEN CONCENTRATOR	Sep 05, 2014	Substantially Equivalent	Longfian Scitech Co., Ltd.
K132489	INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)	Jun 20, 2014	Substantially Equivalent	Inogen, Inc.
K132205	ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM	Jun 06, 2014	Substantially Equivalent	Inova Labs, Inc.
K134023	2300 SERIES MGO PORTABLE OXYGEN	Apr 25, 2014	Substantially Equivalent	Ultra Electronics Limited Precision Air & Land SY
K131990	OXYGEN GENERATOR LIQUEFIER - (OGL)	Feb 21, 2014	Substantially Equivalent	Essex Cryogenics of Missouri, Inc.
K131016	ROGS	Nov 27, 2013	Substantially Equivalent	Molecular Products , Ltd.
K123738	MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD	Feb 28, 2013	Substantially Equivalent	Nidek Medical Products, Inc.
K120785	OMNI 3 OXYGEN SYSTEM	Oct 25, 2012	Substantially Equivalent	Caire, Inc.
K121260	TROOPER OXYGEN CONCENTRATOR	Sep 21, 2012	Substantially Equivalent	Vbox, Inc.
K120566	O2PAK OXYGEN GENERATOR	Jul 24, 2012	Substantially Equivalent	Pacific Precision Products
K121531	A&J 5L POCA SERIES OXYGEN CONCENTRATOR	Jul 17, 2012	Substantially Equivalent	Zhongshan A&J Medical Equipment Co., Ltd.
K121167	CAIRE COMPANION 5 OXYGEN CONCENTRATOR	May 02, 2012	Substantially Equivalent	Caire, Inc.
K113317	LIFECHOICE OXYGEN CONCENTRATOR	Dec 28, 2011	Substantially Equivalent	Inova Labs, Inc.
K111885	SIMPLYGO PORTABLE OXYGEN CONCENTRATOR	Nov 04, 2011	Substantially Equivalent	Respironics, Inc.
K103563	PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150	Jul 01, 2011	Substantially Equivalent	Precision Medical, Inc.
K101154	CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L	Mar 28, 2011	Substantially Equivalent	Airsep Corp.
K102750	O2-IN-A-BOX, O2-IN-A-BOX	Feb 11, 2011	Substantially Equivalent	Geto2, Inc.
K100957	DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION	Jan 21, 2011	Substantially Equivalent	Pacific Consolidated Industries, LLC
K100920	MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES	Nov 29, 2010	Substantially Equivalent	Sequal Technologies Co., Ltd.
K102245	CARE ZY5BA OXYGEN CONCENTRATOR	Nov 09, 2010	Substantially Equivalent	Foshan Care Medical Technology Co., Ltd.
K091716	MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY	Apr 02, 2010	Substantially Equivalent	Merits Health Products Co., Ltd.
K093308	MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD	Jan 14, 2010	Substantially Equivalent	Nidek Medical Products, Inc.
K092636	POGS, MODEL 65/130	Jan 07, 2010	Substantially Equivalent	On Site Gas Systems, Inc.
K091541	MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES	Dec 31, 2009	Substantially Equivalent	Sequal Technologies Co., Ltd.
K091650	AXS-590 SERIES	Nov 24, 2009	Substantially Equivalent	Swr International, Ltd.
K091191	GAS TRANSFILL	Oct 23, 2009	Substantially Equivalent	Respironics Inc., Sleep & Home Respiratory Group
K083163	OMNI 2 OXYGEN SYSTEM	Oct 20, 2009	Substantially Equivalent	Sequal Technologies, Inc.
K083559	YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B	Sep 04, 2009	Substantially Equivalent	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
K090007	JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000	Jul 24, 2009	Substantially Equivalent	Danyang Jumao Healthcare Equipment Co., Ltd.
K091028	OMNI 5 TOTAL O2 DELIVERY SYSTEM	Jul 23, 2009	Substantially Equivalent	Respironics, Inc.
K083751	INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100	May 21, 2009	Substantially Equivalent	Invacare Corporation
K082566	MARK 5 NUVO LITE OCSI AND STD	Dec 03, 2008	Substantially Equivalent	Nidek Medical Products, Inc.
K072348	PRECISION OXYGEN CONCENTRATOR	Oct 27, 2008	Substantially Equivalent	Precision Medical, Inc.
K081267	HYGEIA-5 OXYGEN CONCENTRATOR	Sep 23, 2008	Substantially Equivalent	Kedl Internation Limited
K081508	HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN	Aug 27, 2008	Substantially Equivalent	Shenyang Canta Medical Tech. Co., Ltd.
K081468	DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES	Aug 25, 2008	Substantially Equivalent	Sunrise Medical
K081206	HOMELOX	Jul 28, 2008	Substantially Equivalent	Respironics, Inc.
K080082	OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS	Apr 16, 2008	Substantially Equivalent	Oxlife, LLC
K080391	DRIVE SOLSTICE OXYGEN CONCENTRATOR	Mar 18, 2008	Substantially Equivalent	Medical Depot
K072688	LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000	Jan 11, 2008	Substantially Equivalent	International Biophysics Corp.
K071608	A&J POCA01 OXYGEN CONCENTRATOR	Jan 11, 2008	Substantially Equivalent	Zhongshan A&J Medical Equipment Co., Ltd.
K073242	PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400	Jan 03, 2008	Substantially Equivalent	Delphi Medical Systems
K071928	THE INVACARE FLYER, MODEL IPC 100	Dec 12, 2007	Substantially Equivalent	Invacare Corp.
K071904	DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)	Oct 25, 2007	Substantially Equivalent	Carleton Life Support Systems, Inc.
K071397	DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES	Oct 01, 2007	Substantially Equivalent	Sunrise Medical
K071461	MODEL 300D HOME OXYGEN LIQUEFIER	Aug 21, 2007	Substantially Equivalent	Copd Partners, Inc.
K063454	POGS, MODEL 33C	May 09, 2007	Substantially Equivalent	On Site Gas Systems, Inc.
K061414	EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD	Jan 22, 2007	Substantially Equivalent	Pacific Consolidated Industries, LLC
K062153	PORTABLE OXYGEN GENERATOR SYSTEM	Nov 21, 2006	Substantially Equivalent	Molecular Products , Ltd.
K061261	L4 OXYGEN CONCENTRATOR	Jun 28, 2006	Substantially Equivalent	Respironics, Inc.
K060922	OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5	May 30, 2006	Substantially Equivalent	Oxlife, LLC
K053230	MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS	May 16, 2006	Substantially Equivalent	Merits Health Products Co., Ltd.
K053229	MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS	Mar 23, 2006	Substantially Equivalent	Merits Health Products Co., Ltd.
K053240	DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES	Feb 03, 2006	Substantially Equivalent	Sunrise Medical
K052396	OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615	Dec 09, 2005	Substantially Equivalent	Oxysure Systems, Inc.
K043520	EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR	Oct 21, 2005	Substantially Equivalent	Emg Technology Co., Ltd.
K033405	LONGFEI LFY-I-5 OXYGEN CONCENTRATOR	Oct 18, 2005	Substantially Equivalent	Zhejiang Longfei Industrial Co., Ltd.
K051887	PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)	Sep 27, 2005	Substantially Equivalent	Carleton Life Support Systems, Inc.
K033863	OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03	Aug 22, 2005	Substantially Equivalent	Ox-Gen, Inc.
K050430	MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR	Aug 04, 2005	Substantially Equivalent	Merits Health Products Co., Ltd.
K042944	HOME-AWAY SYSTEM, MODEL 1041	Apr 15, 2005	Substantially Equivalent	In-X Corporation
K043006	MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605	Feb 11, 2005	Substantially Equivalent	Respironics, Inc.
K043615	OXYTEC, MODEL 900	Feb 09, 2005	Substantially Equivalent	Oxytec Medical Corporation
K042262	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	Sep 10, 2004	Substantially Equivalent	Sequal Technologies, Inc.
K041664	PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C	Jul 29, 2004	Substantially Equivalent	On Site Gas Systems, Inc.
K032818	INOGEN ONE OXYGEN CONCENTRATOR	May 13, 2004	Substantially Equivalent	Inogen, Inc.
K040738	MOBILE OXYGEN STORAGE TANK (MOST)	Apr 30, 2004	Substantially Equivalent	Pacific Consolidated Industries Llp
K040892	MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905	Apr 29, 2004	Substantially Equivalent	Nidek Medical Products, Inc.
K032509	MARK 5 NUVO (M5C5)	Mar 18, 2004	Substantially Equivalent	Nidek Medical Products, Inc.
K030920	POGS 33	Mar 10, 2004	Substantially Equivalent	On Site Gas Systems, Inc.
K030233	TRAVELSOME STANDARD	Apr 25, 2003	Substantially Equivalent	Sim Italia S.R.L.
K022684	PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)	Sep 11, 2002	Substantially Equivalent	Essex Cryogenics of Missouri, Inc.
K021685	VENTURE HOMEFILL II WITH OXYGEN CONSERVER	Jul 23, 2002	Substantially Equivalent	Invacare Corp.
K020386	INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02	Jul 02, 2002	Substantially Equivalent	Invacare Corp.
K021082	ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0	May 22, 2002	Substantially Equivalent	On Site Gas Systems, Inc.
K020330	DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)	Apr 12, 2002	Substantially Equivalent	Pacific Consolidated Industries Llp
K013931	OMNI OXYGEN SYSTEM, MODEL 1000	Mar 27, 2002	Substantially Equivalent	Sequal Technologies, Inc.
K020324	LIFESTYLE OXYGEN CONCENTRATOR	Mar 13, 2002	Substantially Equivalent	Airsep Corp.
K020362	P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM	Feb 12, 2002	Substantially Equivalent	On Site Gas Systems, Inc.
K014301	MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS	Feb 11, 2002	Substantially Equivalent	Merits Health Products Co., Ltd.
K013223	PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)	Feb 11, 2002	Substantially Equivalent	Litton Systems, Inc.
K012037	HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009	Jan 17, 2002	Substantially Equivalent	Airsep Corp.
K014078	ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM	Jan 08, 2002	Substantially Equivalent	On Site Gas Systems, Inc.
K004047	HOME-AWAY SYSTEM	Dec 18, 2001	Substantially Equivalent	In-X Corp.
K013472	TOTAL O2	Nov 28, 2001	Substantially Equivalent	Chad Therapeutics, Inc.
K011844	MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS	Aug 28, 2001	Substantially Equivalent	Merits Health Products., Inc.
K003472	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	Jun 04, 2001	Substantially Equivalent	Sequal Technologies, Inc.
K003939	VENTURE HOME FILL II, MODEL IOH 200	Mar 21, 2001	Substantially Equivalent	Invacare Corp.
K991722	DEVILBISS 5 LITER OXYGEN CONCENTRATOR	Nov 03, 1999	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K983627	VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM	Oct 22, 1999	Substantially Equivalent	Invacare Corp.
K993088	PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI	Oct 08, 1999	Substantially Equivalent	Puritan Bennett Corp.
K981047	FRESH AIR	Sep 16, 1999	Substantially Equivalent	Colorado Medtech, Inc.
K991569	HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2	Aug 03, 1999	Substantially Equivalent	02 Marketing Group, Inc.
K984081	EMOX	Mar 17, 1999	Substantially Equivalent	Emox 911 CC
K983777	MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM	Dec 18, 1998	Substantially Equivalent	Invacare Corp.
K982243	CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615	Nov 19, 1998	Substantially Equivalent	Canogen International , Ltd.
K981078	TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000	Jul 23, 1998	Substantially Equivalent	Transtracheal Systems
K972614	TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605	Jan 20, 1998	Substantially Equivalent	Healthdyne Technologies, Inc.
K971889	CHAD TOTAL O2 DELIVERY SYSTEM	Nov 17, 1997	Substantially Equivalent	Chad Therapeutics, Inc.
K971947	INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)	Oct 03, 1997	Substantially Equivalent	Sim Italia S.R.L.
K971964	OXLIFE EXCELL OXYGEN CONCENTRATORS	Aug 15, 1997	Substantially Equivalent	Oxlife, Inc.
K971129	OXYPURE PORTABLE OXYGEN GENERATOR	Jun 24, 1997	Substantially Equivalent	Arbor Research Corp.
K960309	AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)	Feb 28, 1997	Substantially Equivalent	Airsep Corp.
K963042	INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853	Nov 01, 1996	Substantially Equivalent	Sim Italia S.R.L.
K954506	EMOX	Apr 30, 1996	Substantially Equivalent	Medtrak Intl., Inc.
K955549	OXLIFE OXYGEN CONCENTRATORS	Mar 15, 1996	Substantially Equivalent	Oxlife, Inc.
K952941	SUN MODEL OA 3000 OXYGEN ANALYZER	Jan 29, 1996	Substantially Equivalent	Sun Medical Equipment, Inc.
K954271	WESTMED CONDESATE COLLECTION TRAP	Dec 28, 1995	Substantially Equivalent	Westmed Intl.
K953815	5 LPM OXYGEN CONCENTRATOR	Nov 09, 1995	Substantially Equivalent	Devilbiss Health Care, Inc.
K953949	HUMIDIFIER & ACCESSORIES	Oct 16, 1995	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K951882	ECO CHECK (ECOVALVE AND OXYGEN MONITOR)	Oct 16, 1995	Substantially Equivalent	Airsep Corp.
K941145	OXY-GENERATOR	Sep 27, 1995	Substantially Equivalent	Med Systems
K952037	3 LPM OXYGEN CONCENTRATOR	Sep 06, 1995	Substantially Equivalent	Devilbiss Health Care, Inc.
K952268	MODEL DELTA, OM OXYGEN CONCENTRATOR	Aug 11, 1995	Substantially Equivalent	Caire, Inc.
K942082	MODEL 6323 OXYGEN CONCENTRATOR	Dec 08, 1994	Substantially Equivalent	Dynotec Corp.
K933081	OXLIFE OXYGEN CONCENTRATOR	Nov 01, 1994	Substantially Equivalent	Oxlife, Inc.
K924565	SBS MODEL 1615	Sep 09, 1994	Substantially Equivalent	Stand-By-Systems, Inc.
K935370	MINIOX IA OXYGEN ANALYZER	Aug 02, 1994	Substantially Equivalent	Minesafety Appliances Co.
K942357	H-500 ALLIANCE OXYGEN CONCENTRATOR	May 27, 1994	Substantially Equivalent	Healthdyne, Inc.
K931355	WHISPER O2	Mar 25, 1994	Substantially Equivalent	Trilogic Corp.
K924818	MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES	Aug 06, 1993	Substantially Equivalent	Invacare Corp.
K924152	KEYSTONE CONCENTRATOR, MODEL PV5L	Jun 07, 1993	Substantially Equivalent	Devilbiss Health Care, Inc.
K924100	OXYGEN CONCENTRATOR	Mar 19, 1993	Substantially Equivalent	Allied Healthcare Products, Inc.
K923650	SCOTTY	Jan 15, 1993	Substantially Equivalent	Mountain Medical Equipment, Inc.
K924146	OH-500 OXYGEN CONCENTRATOR	Jan 07, 1993	Substantially Equivalent	Healthdyne, Inc.
K914916	ALPINE V	Sep 23, 1992	Substantially Equivalent	Mountain Medical Equipment, Inc.
K914488	MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS	Sep 15, 1992	Substantially Equivalent	Invacare Corp.
K915381	PORTABLE OXYGEN GENERATOR	Mar 11, 1992	Substantially Equivalent	Aequitron Medical, Inc.
K912794	ECONOMATE/PATRIOT	Feb 21, 1992	Substantially Equivalent	Foothills Medical Equipment, Inc.
K913327	CONTEMPRO2 HOME HEALTH CARE REGULATOR	Dec 20, 1991	Substantially Equivalent	Continental Products, Inc.
K904639	GENOX MODEL CT-1	Aug 13, 1991	Substantially Equivalent	Pacific Consolidated Industries
K901712	GUILD MAXOX GENERATOR (MAXOX)	Feb 27, 1991	Substantially Equivalent	Guild Assoc., Inc.
K904087	MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON	Oct 26, 1990	Substantially Equivalent	Invacare Corp.
K904271	OXLIFE	Oct 12, 1990	Substantially Equivalent	Medical Repair Service, Inc.
K903608	V-LINK	Oct 12, 1990	Substantially Equivalent	GE Medical Systems
K904002	GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST	Sep 05, 1990	Substantially Equivalent	Pacific Consolidated Industries
K903411	FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP	Aug 31, 1990	Substantially Equivalent	Guild Assoc., Inc.
K902890	ASPEN 3 OXYGEN CONCENTRATOR	Jul 19, 1990	Substantially Equivalent	Mountain Medical Equipment, Inc.
K896457	DEVILBISS MODEL PV02 SERIES	Feb 01, 1990	Substantially Equivalent	Devilbiss Health Care, Inc.
K895177	PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR	Nov 21, 1989	Substantially Equivalent	Puritan Bennett Corp.
K895141	MODEL 590 OXYGEN CONCENTRATOR	Oct 31, 1989	Substantially Equivalent	Puritan Bennett Corp.
K894384	K.E.E. OXYGEN CONCENTRATOR	Oct 27, 1989	Substantially Equivalent	Kee Medical Services, Inc.
K891488	MOBILAIRE V OXYGEN CONCENTRATOR	May 25, 1989	Substantially Equivalent	Invacare Corp.
K884563	OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%	Apr 26, 1989	Substantially Equivalent	Ivex Medical, Inc.
K884018	LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT	Feb 27, 1989	Substantially Equivalent	Lamelli Pulmonary Research Center
K890150	H-3000 OXYGEN CONCENTRATOR	Jan 31, 1989	Substantially Equivalent	Healthdyne, Inc.
K884581	RELIANT OXYGEN CONCENTRATOR	Jan 11, 1989	Substantially Equivalent	Airsep Corp.
K883837	MIKADO AC 405	Dec 12, 1988	Substantially Equivalent	Ivex Medical, Inc.
K884084	PORTABLE OXYGEN GENERATOR	Nov 21, 1988	Substantially Equivalent	Mountain Medical Equipment, Inc.
K883591	MARK-5 CONCENTRATOR	Nov 02, 1988	Substantially Equivalent	Nidek Medical Products, Inc.
K881802	ALPINE PORTABLE OXYGEN GENERATOR	Jul 08, 1988	Substantially Equivalent	Mountain Medical Equipment, Inc.
K880044	OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8	Mar 28, 1988	Substantially Equivalent	Oxygen Enrichment Company, Ltd.
K873526	PALL FIELD MEDICAL OXYGEN GENERA. & DISTRI. SYSTEM	Feb 29, 1988	Substantially Equivalent	Pall Safety Atmospheres, Inc.
K880262	MOBILE PAK, MODEL DC	Feb 12, 1988	Substantially Equivalent	Intl. Biomedical Concepts, Inc.
K880261	MOBILE PAK, MODEL AC	Feb 12, 1988	Substantially Equivalent	Intl. Biomedical Concepts, Inc.
K873156	AMOX OXYGEN GENERATORS	Jan 22, 1988	Substantially Equivalent	Vbm Corp.
K873284	OXYGEN/STERILE AIR GEN SYST/SURGICAL HANDPIECES	Nov 16, 1987	Substantially Equivalent	Litton Systems, Inc.
K872534	4LYF OXYGEN CONCENTRATOR	Oct 13, 1987	Substantially Equivalent	Airsep Corp.
K873071	BUNN CONCENTRATOR MODEL 2100 SERIES	Sep 15, 1987	Substantially Equivalent	The John Bunn Co.
K871603	CRITERION II & IIA OXYGEN CONCENTRATORS	Aug 13, 1987	Substantially Equivalent	Timeter Instrument Corp.
K872470	DEVO/MC44 OXYGEN CONCENTRATOR	Aug 03, 1987	Substantially Equivalent	The Devilbiss Co.
K870064	MOBIL-AIR	Feb 11, 1987	Substantially Equivalent	Roman Laboratories, Inc.
K864005	ALPINE	Jan 28, 1987	Substantially Equivalent	Mountain Medical Equipment, Inc.
K864045	PORTABLE OXYGEN GENERATOR	Nov 07, 1986	Substantially Equivalent	Mountain Medical Equipment, Inc.
K861435	BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE	Nov 07, 1986	Substantially Equivalent	The John Bunn Co.
K862194	INHALATOR MODELS 8100, 10100 AND 10200	Jul 28, 1986	Substantially Equivalent	U.O. Equipment Co.
K861012	SILENT PARTNER MODEL 10-1001	Apr 04, 1986	Substantially Equivalent	Medical Devices, Inc.
K861011	SILENT PARTNER MODEL 10-2001	Apr 04, 1986	Substantially Equivalent	Medical Devices, Inc.
K854748	TRAVELPAK MODEL DC-202	Feb 26, 1986	Substantially Equivalent	Travomed, Inc.
K855208	BUNN LITE OXYGEN CONCENTRATOR	Feb 21, 1986	Substantially Equivalent	The John Bunn Co.
K860060	RX02 PLUS OXYGEN CONCENTRATOR	Feb 05, 1986	Substantially Equivalent	The John Bunn Co.
K854509	TRAVELPAK MODEL AC-102	Jan 28, 1986	Substantially Equivalent	Travomed, Inc.
K854374	OXYGEN CONCENTRATOR, MODEL BX-5000	Jan 03, 1986	Substantially Equivalent	Healthdyne, Inc.
K853004	PORTABLE OXYGEN UNIT	Aug 29, 1985	Substantially Equivalent	B & F Medical Products, Inc.
K852144	SIERRA -OXYGEN CONCENTRATE	Aug 13, 1985	Substantially Equivalent	Mountain Medical Equipment, Inc.
K851439	MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR	Jul 29, 1985	Substantially Equivalent	Invacare Corp.
K851438	MOBILAIRE II(P2A) OXYGEN CONCENTRATOR	Jul 29, 1985	Substantially Equivalent	Invacare Corp.
K851437	PRIME AIRE O2 PLUS 2	Jul 29, 1985	Substantially Equivalent	Invacare Corp.
K851435	PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR	Jul 29, 1985	Substantially Equivalent	Invacare Corp.
K851434	MOBILAIRE III P3 OXYGEN CONCENTRATOR	Jul 29, 1985	Substantially Equivalent	Invacare Corp.
K852209	DEVO/MC29 OXYGEN CONCENTRATOR MC29D	Jun 24, 1985	Substantially Equivalent	The Devilbiss Co.
K850346	OXYGEN CONCENTRATOR	Feb 04, 1985	Substantially Equivalent	Inspiron Corp.
K850253	ECONO MATE -OXYGEN CONCENTRATOR	Feb 01, 1985	Substantially Equivalent	Mountain Medical Equipment, Inc.
K844852	THE GENERIC OXYGEN CONCENTRATOR	Dec 27, 1984	Substantially Equivalent	Proto-Med, Inc.
K844312	ME-TOO OXYGEN CONCENTRATOR	Dec 24, 1984	Substantially Equivalent	Medequip Co.
K844223	PREMIER O2 OXYGEN CONCENTRATOR	Dec 24, 1984	Substantially Equivalent	Everest & Jennings, Inc.
K844328	OXYGEN CONCENTRATOR	Dec 04, 1984	Substantially Equivalent	Hospitak, Inc.
K843691	PORTABLE OXYGEN UNIT	Nov 07, 1984	Substantially Equivalent	B & F Medical Products, Inc.
K843715	ECONO MATE	Oct 10, 1984	Substantially Equivalent	Mountain Medical Equipment, Inc.
K843811	BUNN 3001 OXYGEN CONCENTRATOR	Oct 04, 1984	Substantially Equivalent	The John Bunn Co.
K843243	COMPANION 492 OXYGEN CONCENTRATOR	Aug 22, 1984	Substantially Equivalent	Puritan Bennett Corp.
K842753	OXYGEN CONCENTRATOR	Aug 15, 1984	Substantially Equivalent	Bv Medical Equipment Co.
K842114	CONCENTRACTORS	Jun 15, 1984	Substantially Equivalent	Amox Corp.
K841102	BUNN 1000 OXYGEN CONCENTRATOR	Apr 13, 1984	Substantially Equivalent	The John Bunn Co.
K834274	CRITERION I	Apr 13, 1984	Substantially Equivalent	Timeter Instrument Corp.
K833938	CATALOG 6400 OXYGEN CONCENTRATOR	Dec 08, 1983	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K833500	MAX 02 OXYGEN CONCENTRATOR	Nov 29, 1983	Substantially Equivalent	Mountain Medical Equipment, Inc.
K833495	BUNN MICRO OXYGEN CONCENTRATOR	Nov 29, 1983	Substantially Equivalent	Greene & Kellogg, Inc.
K831819	OXYGEN CONCENTRATOR RESPIRATORY SUPPOR	Nov 22, 1983	Substantially Equivalent	Eagle Medical Equipment Co.
K830324	AIRCARE 300	Mar 10, 1983	Substantially Equivalent	Med.Com
K830174	DE VO/44 OXYGEN CONCENTRATOR #444	Feb 17, 1983	Substantially Equivalent	The Devilbiss Co.
K830046	MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY	Feb 07, 1983	Substantially Equivalent	Greene & Kellogg, Inc.
K823172	MEDOX OXYGEN SYSTEM	Feb 01, 1983	Substantially Equivalent	Mepecc Intl.
K823582	OXYGEN CONCENTRATOR UCC-100	Jan 05, 1983	Substantially Equivalent	Linde Div. Union Carbide Corp.
K823524	OXYGEN CONCENTRATOR	Dec 28, 1982	Substantially Equivalent	C.R. Bard, Inc.
K822889	MODEL #6200 OXYGEN CONCENTRATOR	Oct 22, 1982	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K822871	MODEL BX-3000 OXYGEN CONCENTRATOR	Oct 22, 1982	Substantially Equivalent	Healthdyne, Inc.
K822789	ROOMATE II	Oct 15, 1982	Substantially Equivalent	Cryogenic Assoc.
K822301	ROYAL 1 OXYGEN CONCENTRATOR	Aug 19, 1982	Substantially Equivalent	Proto-Med, Inc.
K821393	SYSTEM ONE OXYGEN CONCENTRATOR	Aug 10, 1982	Substantially Equivalent	Marathon
K821520	MODEL 379 FLOW/DIVIDER	Jun 02, 1982	Substantially Equivalent	Marathon
K813436	OXYCON	Jan 07, 1982	Substantially Equivalent	Home Medical Mfg., Co., Inc.
K813320	MODEL 6200 OXYGEN CONCENTRATOR	Dec 31, 1981	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K813058	PORTABLE OXYGEN GENERATOR	Dec 03, 1981	Substantially Equivalent	Respiratory Marketing, Inc.
K813018	OXYTRON OXYGEN GENERATOR	Nov 06, 1981	Substantially Equivalent	Elmore Technology Corp.
K812282	PORTABLE OXYGEN GENERATOR	Oct 23, 1981	Substantially Equivalent	American Marketing Assoc., Inc.
K812693	LIF-O-GEN #3000 OXYGEN CONCENTRATOR	Oct 13, 1981	Substantially Equivalent	Lif-O-Gen, Inc.
K812513	MINI O2	Sep 21, 1981	Substantially Equivalent	Mountain Medical Equipment, Inc.
K811155	MODEL RXO2 OXYGEN RICH AIR SUPPLY	May 05, 1981	Substantially Equivalent	Greene & Kellogg, Inc.
K810411	PORTABLE OXYGEN GENERATOR	Feb 26, 1981	Substantially Equivalent	Supplemental Oxygen Systems, Inc.
K810272	BIO CARE OXYGEN CONCENTRATOR	Feb 25, 1981	Substantially Equivalent	The Biomed Group
K803232	COMPRESSED AIR & OXYGEN GEN./DELIVERY SY	Feb 02, 1981	Substantially Equivalent	Dri-Aire, Inc.
K802426	RESPO2 OXYGEN CONCENTRATOR	Oct 23, 1980	Substantially Equivalent	Mada Medical Products, Inc.
K801523	MODEL 379 WXYGEN CONCENTRATOR	Jul 14, 1980	Substantially Equivalent	Stanley Aviation Corp.
K801104	ROOMMATE-OXYGEN CONCENTRATOR	May 23, 1980	Substantially Equivalent	Cryogenic Assoc.
K792385	DEVO OXYGEN CONCENTRATOR, MODEL 955	Dec 05, 1979	Substantially Equivalent	The Devilbiss Co.
K792149	MTC OXYGEN CONCENTRATOR, OR PRIME-AIRE	Nov 13, 1979	Substantially Equivalent	Molecular Technologies Corp.
K791437	LINDE OXYGEN CONCENTRATOR LOC-II	Sep 19, 1979	Substantially Equivalent	Union Carbide Corp.
K791043	LINDE OXYGEN CONCENTRATOR MODEL LOC-HC	Jun 13, 1979	Substantially Equivalent	Union Carbide Corp.
K790520	AIRCARE OXYGEN GENERATOR	Apr 18, 1979	Substantially Equivalent	Medical Services of America, Inc.
K781300	OXYGEN CONCENTRATOR	Oct 16, 1978	Substantially Equivalent	Bendix Instruments & Life Support Div
K781074	OXYGEN RICH AIR SUPPLY UNIT-MODEL 390	Aug 31, 1978	Substantially Equivalent	Xorbox
K780862	MODEL 290 OXYGEN RICH AIR SUPPLY UNIT	Aug 14, 1978	Substantially Equivalent	The John Bunn Co.
K780366	SOLID-OX EMERGENCY OXYGEN	Apr 07, 1978	Substantially Equivalent	Cleanweld Products, Inc.
K780020	GENERATOR, OXYGEN, PORTABLE	Jan 26, 1978	Substantially Equivalent	Jet Research Center, Inc.
K771761	SOLID OXYGEN SYSTEM	Oct 04, 1977	Substantially Equivalent	Jet Research Center, Inc.
K771665	OXYGEN CONCENTRATOR	Sep 12, 1977	Substantially Equivalent	Mtc
K770157	DEVILBISS OXYGEN ENRICHER	Feb 07, 1977	Substantially Equivalent	The Devilbiss Co.
K761213	AIR ENRICHER	Dec 16, 1976	Substantially Equivalent	Union Carbide Corp.
K760705	OXYGEN-RICH	Oct 05, 1976	Substantially Equivalent	The John Bunn Co.
K760704	OXYGEN-RICH	Oct 05, 1976	Substantially Equivalent	Xorbox