Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5440](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5440) → CAW — Generator, Oxygen, Portable # CAW · Generator, Oxygen, Portable _Anesthesiology · 21 CFR 868.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW ## Overview - **Product Code:** CAW - **Device Name:** Generator, Oxygen, Portable - **Regulation:** [21 CFR 868.5440](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5440) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K252407.md) | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | Apr 23, 2026 | SESE | | [K253549](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K253549.md) | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | Mar 26, 2026 | SESE | | [K251534](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K251534.md) | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | Dec 29, 2025 | SESE | | [K252616](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K252616.md) | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | Dec 22, 2025 | SESE | | [K251764](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K251764.md) | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | Dec 22, 2025 | SESE | | [K252268](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K252268.md) | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | Dec 16, 2025 | SESE | | [K250805](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K250805.md) | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | Dec 9, 2025 | SESE | | [K251607](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K251607.md) | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | Nov 21, 2025 | SESE | | [K243833](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K243833.md) | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | Sep 29, 2025 | SESE | | [K250625](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K250625.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K251130.md) | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Aug 21, 2025 | SESE | | [K250671](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K250671.md) | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | Jul 11, 2025 | SESE | | [K242736](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K242736.md) | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Jun 5, 2025 | SESE | | [K242718](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K242718.md) | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | Feb 28, 2025 | SESE | | [K240840](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K240840.md) | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | Dec 6, 2024 | SESE | | [K240561](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K240561.md) | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. | Dec 6, 2024 | SESE | | [K230969](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K230969.md) | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Nov 9, 2023 | SESE | | [K230702](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K230702.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K223740.md) | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | Oct 5, 2023 | SESE | | [K222920](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW/K222920.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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