Cleared Traditional

Portable Oxygen Concentrator (JM-P50A)

K251130 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Anesthesiology
Aug 2025
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K251130 is an FDA 510(k) clearance for the Portable Oxygen Concentrator (JM-P50A), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on August 21, 2025, 132 days after receiving the submission on April 11, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K251130 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date August 21, 2025
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

Similar Devices — CAW Generator, Oxygen, Portable

All 282
Oxygen Concentrator (J10A)
K251534 · Foshan Kycare Medical Equipment Co., Ltd. · Dec 2025
Oxygen Concentrator-P2-O5E
K251764 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Dec 2025
Portable oxygen concentrator (JLO-190P)
K252616 · Shenzhen Homed Medical Device Co., Ltd. · Dec 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · Shenzhen Harveymed Technology Co., Ltd. · Dec 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
K250805 · Devilbiss Healthcare, LLC · Dec 2025
Oxygen Concentrator (J5A)
K251607 · Foshan Kycare Medical Equipment Co., Ltd. · Nov 2025