CAW
- Product code
- CAW
- Device name
- Generator, Oxygen, Portable
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5440
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 22
- Summaries archived here
- 19 (direct download)
- 510(k) clearances (all years, FDA)
- 288 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (22)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260171 | 2026-08-14 | BMC Medical Co., Ltd. | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | |
| K252399 | 2026-06-17 | Honsun (Nantong) Co., Ltd. | Portable Oxygen Concentrator | |
| K252965 | 2026-05-29 | Oxytek Medical Technology Co., Ltd. | Oxygen Concentrator (OX-5A, OX-5C) | |
| K252407 | 2026-04-23 | Mv Life, LLC | OxyGo Portable Oxygen Concentrator (1400-7000) | |
| K253549 | 2026-03-26 | Devilbiss Healthcare, LLC | DeVilbiss 5 Liter Oxygen Concentrator (555) | |
| K251534 | 2025-12-29 | Foshan Kycare Medical Equipment Co., L… | Oxygen Concentrator (J10A) | |
| K251764 | 2025-12-22 | Qingdao Kingon Medical Science and Tec… | Oxygen Concentrator-P2-O5E | |
| K252616 | 2025-12-22 | Shenzhen Homed Medical Device Co., Ltd… | Portable oxygen concentrator (JLO-190P) | |
| K252268 | 2025-12-16 | Shenzhen Harveymed Technology Co., Ltd… | V series portable oxygen concentrator (V5, V5C, V6, … | |
| K250805 | 2025-12-09 | Devilbiss Healthcare, LLC | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060A… | |
| K251607 | 2025-11-21 | Foshan Kycare Medical Equipment Co., L… | Oxygen Concentrator (J5A) | |
| K243833 | 2025-09-29 | Longfian Scitech Co., Ltd. | Portable oxygen concentrator (JAY-1000P) | |
| K250625 | 2025-08-27 | Nanjing Yinuoji Medical Technology Co.… | Portable oxygen concentrator (W-R1(MAX)); Portable … | |
| K251130 | 2025-08-21 | Jiangsu Jumao X-Care Medical Equipment… | Portable Oxygen Concentrator (JM-P50A) | |
| K250671 | 2025-07-11 | Caire, Inc. | FreeStyle Comfort (AS200 / FreeStyle Comfort) | |
| K242736 | 2025-06-05 | Jiangsu Yuyue Medical Equipment & Supp… | Portable Oxygen Concentrator (Spirit-3) | |
| K242718 | 2025-02-28 | Qingdao Kingon Medical Science and Tec… | Portable Oxygen Concentrator (P2-TOC) | FDA |
| K240561 | 2024-12-06 | Molecular Products , Ltd. | Rugged Oxygen Generator (ROG) (RO01-00001) | |
| K240840 | 2024-12-06 | Foshan Care Medical Technology Co., Lt… | Oxygen Concentrator (ZY-10AB/115) | |
| K230969 | 2023-11-09 | Jiangsu Jumao X-Care Medical Equipment… | Oxygen Concentrator | FDA |
| K230702 | 2023-10-18 | Qingdao Kingon Medical Science and Tec… | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2… | |
| K223740 | 2023-10-05 | Jiangsu Konsung Bio-Medical Science an… | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | — |
Official FDA classification page: CAW
Classification and pathway per current FDA publications. Data from openFDA (CC0).