CAW · Generator, Oxygen, Portable
Anesthesiology · 21 CFR 868.5440 · Class 2
Overview
| Product Code | CAW |
|---|---|
| Device Name | Generator, Oxygen, Portable |
| Regulation | 21 CFR 868.5440 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 285)
Showing 20 most recent of 285 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | Apr 23, 2026 | SESE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | Mar 26, 2026 | SESE |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | Dec 29, 2025 | SESE |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | Dec 22, 2025 | SESE |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | Dec 22, 2025 | SESE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | Dec 16, 2025 | SESE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | Dec 9, 2025 | SESE |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | Nov 21, 2025 | SESE |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | Sep 29, 2025 | SESE |
| K250625 | 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. | Aug 27, 2025 | SESE |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Aug 21, 2025 | SESE |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | Jul 11, 2025 | SESE |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Jun 5, 2025 | SESE |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | Feb 28, 2025 | SESE |
| K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | Dec 6, 2024 | SESE |
| K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. | Dec 6, 2024 | SESE |
| K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Nov 9, 2023 | SESE |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science and Technology Co., Ltd. | Oct 18, 2023 | SESE |
| K223740 | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | Oct 5, 2023 | SESE |
| K222920 | Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. | Jul 20, 2023 | SESE |
Top Applicants
- Invacare Corp. — 15 clearances
- Mountain Medical Equipment, Inc. — 12 clearances
- The John Bunn Co. — 8 clearances
- Airsep Corp. — 7 clearances
- Nidek Medical Products, Inc. — 7 clearances
