Home › Device types › CAW
Generator, Oxygen, Portable
FDA product code CAW · Class 2 · Anesthesiology
615
Registered devices
52,785
Adverse events
44
Recalls
288
510(k) clearances
Devices with this code
X-PLO2R — BELLUSCURA PLCNewLife Elite — AIRSEP CORPORATIONEverFlo — Respironics, Inc.HomeFill® Oxygen System — Ventec Life Systems, Inc.ViveBreathe — VIVE HEALTH LLCFreeStyle 5 — CAIRE INC.Invacare® HomeFill® Cylinder Bag — INVACARE CORPORATIONDeVilbiss — DEVILBISS HEALTHCARE LLCDeVilbiss — DEVILBISS HEALTHCARE LLCInogen One G2 Oxygen Concentrator — Inogen, Inc.Procure — Twin Med, LLCMARK 5 NUVO LITE — NIDEK MEDICAL PRODUCTS, INC.DeVilbiss — DEVILBISS HEALTHCARE LLCFreeStyle — AIRSEP CORPORATIONInogen Rove 4 — Inogen, Inc.NewLife Intensity — CAIRE INC.FreeStyle 5 — AIRSEP CORPORATIONNewLife Elite — AIRSEP CORPORATIONX-PLO2R — BELLUSCURA PLCMARK 5 NUVO 10 — NIDEK MEDICAL PRODUCTS, INC.NewLife Intensity 10 — AIRSEP CORPORATIONSimplyGo,Argentina — Respironics, Inc.MICITECH — Foshan MIC Medical Technology Co.,Ltd.MICITECH — Foshan MIC Medical Technology Co.,Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-04 | 3B Medical, Inc. | Devices which did not meet internal quality specifications were inadvertently distributed. |
| 2025-10-07 | Philips Respironics, Inc. | Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage ou |
| 2025-05-08 | Ohio Medical Corporation | Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indic |
| 2025-04-11 | Medical Depot Inc. | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. |
| 2024-12-09 | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD | Oxygen concentrator may melt or catch on fire during use. |
| 2024-10-04 | Caire, Inc. | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2024-10-04 | Caire, Inc. | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2024-10-04 | Caire, Inc. | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2024-10-04 | Caire, Inc. | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| 2023-03-09 | DeVilbiss Healthcare LLC | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. |
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