CAWFDA Class 2 · 21 CFR 868.5440
Generator, Oxygen, Portable
Device family · Anesthesiology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
285
Manufacturers
30
Flagged signals
18
Adverse-event reports
51,843
Code matrix
| FDA product code | CAW |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2023 | 4 | 73.9 | 220 |
| Other | 2011 | 16 | 47.7 | 687 |
| Other | 2010 | 5 | 14.9 | 52 |
| Death | 2025 | 10 | 9.2 | 65 |
| Other | 2010 | 3 | 8.9 | 14 |
| Other | 2012 | 11 | 7.2 | 53 |
| Death | 2025 | 12 | 6.9 | 55 |
| Death | 2012 | 6 | 6.0 | 20 |
| Death | 2021 | 5 | 5.6 | 15 |
| Death | 2015 | 5 | 5.0 | 12 |
| Death | 2011 | 5 | 5.0 | 12 |
| Death | 2016 | 9 | 4.7 | 23 |
| Death | 2021 | 8 | 4.6 | 19 |
| Death | 2014 | 4 | 4.0 | 6 |
| Other | 2013 | 6 | 3.9 | 10 |
| Death | 2022 | 7 | 3.6 | 11 |
| Death | 2020 | 6 | 3.5 | 8 |
| Death | 2024 | 6 | 3.1 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 51,843 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Invacare Corp. | 15 | 2007 | — |
| ON SITE GAS SYSTEMS, INC. | 7 | 2010 | — |
| NIDEK MEDICAL PRODUCTS, INC. | 7 | 2020 | — |
| INVACARE CORPORATION | 5 | 2021 | 0.80 |
| Qingdao Kingon Medical Science and Technology Co., Ltd. | 5 | 2025 | — |
| Respironics, Inc. | 5 | 2011 | — |
| MERITS HEALTH PRODUCTS CO., LTD. | 5 | 2010 | — |
| Caire, Inc. | 4 | 2025 | — |
| Puritan Bennett Corp. | 4 | 1999 | — |
| Inogen, Inc. | 3 | 2023 | — |
| Union Carbide Corp. | 3 | 1979 | — |
| JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. | 3 | 2025 | — |
| Longfian Scitech Co., Ltd. | 3 | 2025 | — |
| Zhongshan A&J Medical Equipment Co., Ltd. | 2 | 2012 | — |
| Precision Medical, Inc. | 2 | 2011 | — |
| Foshan KYCARE Medical Equipment Co., Ltd. | 2 | 2025 | — |
| Medical Devices, Inc. | 2 | 1986 | — |
| Inova Labs, Inc. | 2 | 2014 | — |
| GE Medical Systems | 1 | 1990 | — |
| Shenzhen Homed Medical Device Co., Ltd. | 1 | 2025 | — |
| Shenyang Canta Medical Tech. Co., Ltd. | 1 | 2008 | — |
| Zhengzhou Olive Electronic Technology Co., Ltd. | 1 | 2023 | — |
| AIRSEP CORPORATION | 1 | 2015 | — |
| Foshan MIC Medical Technology Co., LTD. | 1 | 2022 | — |
| Guangzhou Life Light Electronic Technology Co., Ltd. | 1 | 2020 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
OxyGo Portable Oxygen Concentrator (1400-7000) · Mv Life, LLC510(k) · 2026-04-23
DeVilbiss 5 Liter Oxygen Concentrator (555) · Devilbiss Healthcare, LLC510(k) · 2026-03-26
Oxygen Concentrator (J10A) · Foshan Kycare Medical Equipment Co., Ltd.510(k) · 2025-12-29
Portable oxygen concentrator (JLO-190P) · Shenzhen Homed Medical Device Co., Ltd.510(k) · 2025-12-22
Oxygen Concentrator-P2-O5E · Qingdao Kingon Medical Science and Technology Co., Ltd.510(k) · 2025-12-22
V series portable oxygen concentrator (V5, V5C, V6, V6C) · Shenzhen Harveymed Technology Co., Ltd.510(k) · 2025-12-16
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) · Devilbiss Healthcare, LLC510(k) · 2025-12-09
Oxygen Concentrator (J5A) · Foshan Kycare Medical Equipment Co., Ltd.510(k) · 2025-11-21
Portable oxygen concentrator (JAY-1000P) · Longfian Scitech Co., Ltd.510(k) · 2025-09-29
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) · Nanjing Yinuoji Medical Technology Co., Ltd.510(k) · 2025-08-27
Portable Oxygen Concentrator (JM-P50A) · Jiangsu Jumao X-Care Medical Equipment Co., Ltd.510(k) · 2025-08-21
FreeStyle Comfort (AS200 / FreeStyle Comfort) · Caire, Inc.510(k) · 2025-07-11
Portable Oxygen Concentrator (Spirit-3) · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.510(k) · 2025-06-05
Portable Oxygen Concentrator (P2-TOC) · Qingdao Kingon Medical Science and Technology Co., Ltd.510(k) · 2025-02-28
Oxygen Concentrator (ZY-10AB/115) · Foshan Care Medical Technology Co., Ltd.510(k) · 2024-12-06
Rugged Oxygen Generator (ROG) (RO01-00001) · Molecular Products , Ltd.510(k) · 2024-12-06
Oxygen Concentrator · Jiangsu Jumao X-Care Medical Equipment Co., Ltd.510(k) · 2023-11-09
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) · Qingdao Kingon Medical Science and Technology Co., Ltd.510(k) · 2023-10-18
Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) · Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.510(k) · 2023-10-05
Oxygen concentrator · Zhengzhou Olive Electronic Technology Co., Ltd.510(k) · 2023-07-20
Inogen Rove 6 · Inogen, Inc.510(k) · 2023-06-30
Portable Oxygen Concentrator (Model: P2-E7, P2-E) · Qingdao Kingon Medical Science and Technology Co., Ltd.510(k) · 2023-06-22
Oxus Sieve Beds · Oxus, Inc.510(k) · 2023-05-31
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.510(k) · 2023-04-28
Inogen Rove 4 Portable Oxygen Concentrator · Inogen510(k) · 2022-12-09
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.