ClearanceBrief
Panels › Anesthesiology › Product code CAW · Class 2

Generator, Oxygen, Portable

Regulation 868.5440

12510(k)s in 12 months (289 all time)
2recalls in 12 months (44 all time)
35recalls that name a 510(k)
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Top companies in CAW

DateFirm and productCodeLinked 510(k)
Apr 15, 20263B Medical, Inc.
React Health PHOENIX 5L Oxygen Concentrator
Open, Classified
CAWK213210
Nov 7, 2025Philips Respironics, Inc.
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Open, Classified
CAWNone listed
Jun 13, 2025Ohio Medical Corporation
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Open, Classified
CAWK162433
May 9, 2025Medical Depot Inc.
iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Open, Classified
CAWK071397
Jan 3, 2025JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Open, Classified
CAWK230969
Nov 15, 2024Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Completed
CAWNone listed
Nov 15, 2024Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Completed
CAWNone listed
Nov 15, 2024Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Completed
CAWK020324
Nov 15, 2024Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Completed
CAWK020324
May 4, 2023DeVilbiss Healthcare LLC
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Open, Classified
CAWK071397
Dec 19, 2022DeVilbiss Healthcare LLC
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Open, Classified
CAWK071397
Nov 11, 2022DeVilbiss Healthcare LLC
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Open, Classified
CAWK172648
Jun 10, 2022Invacare Corporation
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Open, Classified
CAWK203210
Mar 25, 2022Caire, Inc.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Terminated
CAWNone listed
Oct 30, 2020Invacare Corporation
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5
Terminated
CAWK200890
Nov 21, 2019Caire, Inc.
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for
Terminated
CAWNone listed
Sep 16, 2019Caire, Inc.
SAROS Oxygen System Model 3000
Terminated
CAWK083163
Oct 9, 2017Inovo, Inc
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Terminated
CAWK080391
Jul 21, 2016Inovo, Inc
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
Terminated
CAWK141967
Jul 24, 2015Oxysure Systems, Inc.
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Terminated
CAWK052396
Dec 24, 2014Invacare Corporation
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Terminated
CAWK020386
Dec 12, 2014Invacare Corporation
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished
Terminated
CAWK020386
Jan 8, 2014On Site Gas Systems Inc.
On Site Gas Systems POGS 33C Portable Oxygen Generation System
Terminated
CAWNone listed
Feb 2, 2013Oxus America, Inc.
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen fo
Terminated
CAWK020324
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Terminated
CAWK032509
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
Terminated
CAWK032509
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Terminated
CAWK032509
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Terminated
CAWK032509
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Terminated
CAWNone listed
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Terminated
CAWK032509
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
Terminated
CAWNone listed
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Terminated
CAWK032509
Jun 19, 2012Nidek Medical Products Inc
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Terminated
CAWK032509
Feb 24, 2011Invacare Corporation
HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 1
Terminated
CAWK003939
Dec 23, 2009Sequal Technologies Inc
SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.
Terminated
CAWK013931
Sep 16, 2009Carleton Life Support Systems Inc
Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton
Terminated
CAWK082829
Dec 30, 2008Sunrise Medical
DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.
Terminated
CAWK991722
Aug 28, 2008Pacific Consolidated Industries LLC
Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002
Terminated
CAWK040738
K061414
Jul 23, 2008Medline Industries Inc
Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to
Terminated
CAWK043520
Jul 23, 2008Medline Industries Inc
Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to pat
Terminated
CAWK043520
Oct 17, 2006Sunrise Medical
DeVilbiss iFill Personal Oxygen Station model number 535D.
Terminated
CAWK053240
Aug 12, 2005Inogen, Inc
Portable Oxygen Generator
Terminated
CAWK032818
Jun 12, 2003System 02 Inc
Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, In
Terminated
CAWNone listed
Jun 12, 2003System 02 Inc
System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetr
Terminated
CAWK991569

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