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)
Top companies in CAW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2026 | 3B Medical, Inc. React Health PHOENIX 5L Oxygen Concentrator Open, Classified |
CAW | K213210 |
| Nov 7, 2025 | Philips 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 |
CAW | None listed |
| Jun 13, 2025 | Ohio Medical Corporation GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Open, Classified |
CAW | K162433 |
| May 9, 2025 | Medical 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 |
CAW | K071397 |
| Jan 3, 2025 | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L Open, Classified |
CAW | K230969 |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. Completed |
CAW | None listed |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. Completed |
CAW | None listed |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. Completed |
CAW | K020324 |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. Completed |
CAW | K020324 |
| May 4, 2023 | DeVilbiss Healthcare LLC DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR Open, Classified |
CAW | K071397 |
| Dec 19, 2022 | DeVilbiss Healthcare LLC DeVilbiss, 525 5-liter Oxygen Concentrator
Models 525DS, 525DS-Q Open, Classified |
CAW | K071397 |
| Nov 11, 2022 | DeVilbiss Healthcare LLC 125 series iGO2 Portable Oxygen Concentrator-indicated for the
administration of supplemental oxygen.
Models: 125D, 125D-XB Open, Classified |
CAW | K172648 |
| Jun 10, 2022 | Invacare Corporation Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) Open, Classified |
CAW | K203210 |
| Mar 25, 2022 | Caire, Inc. CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 Terminated |
CAW | None listed |
| Oct 30, 2020 | Invacare 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 |
CAW | K200890 |
| Nov 21, 2019 | Caire, 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 |
CAW | None listed |
| Sep 16, 2019 | Caire, Inc. SAROS Oxygen System Model 3000 Terminated |
CAW | K083163 |
| Oct 9, 2017 | Inovo, Inc PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S Terminated |
CAW | K080391 |
| Jul 21, 2016 | Inovo, 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 |
CAW | K141967 |
| Jul 24, 2015 | Oxysure Systems, Inc. OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. Terminated |
CAW | K052396 |
| Dec 24, 2014 | Invacare Corporation Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box. Terminated |
CAW | K020386 |
| Dec 12, 2014 | Invacare 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 |
CAW | K020386 |
| Jan 8, 2014 | On Site Gas Systems Inc. On Site Gas Systems POGS 33C Portable Oxygen Generation System Terminated |
CAW | None listed |
| Feb 2, 2013 | Oxus 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 |
CAW | K020324 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W.
Oxygen Concentrator. Terminated |
CAW | None listed |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Jun 19, 2012 | Nidek Medical Products Inc NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W.
Oxygen Concentrator. Terminated |
CAW | K032509 |
| Feb 24, 2011 | Invacare Corporation HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 1 Terminated |
CAW | K003939 |
| Dec 23, 2009 | Sequal Technologies Inc SeQual Technologies Inc. Eclipse Oxygen System, Model 1000
Indicated for the administration of supplemental oxygen. Terminated |
CAW | K013931 |
| Sep 16, 2009 | Carleton 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 |
CAW | K082829 |
| Dec 30, 2008 | Sunrise 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 |
CAW | K991722 |
| Aug 28, 2008 | Pacific Consolidated Industries LLC Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002 Terminated |
CAW | K040738 K061414 |
| Jul 23, 2008 | Medline 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 |
CAW | K043520 |
| Jul 23, 2008 | Medline 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 |
CAW | K043520 |
| Oct 17, 2006 | Sunrise Medical DeVilbiss iFill Personal Oxygen Station model number 535D. Terminated |
CAW | K053240 |
| Aug 12, 2005 | Inogen, Inc Portable Oxygen Generator Terminated |
CAW | K032818 |
| Jun 12, 2003 | System 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 |
CAW | None listed |
| Jun 12, 2003 | System 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 |
CAW | K991569 |
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