Cleared Traditional

Oxygen Concentrator (J10A)

K251534 · Foshan Kycare Medical Equipment Co., Ltd. · Anesthesiology

Dec 2025

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K251534 is an FDA 510(k) clearance for the Oxygen Concentrator (J10A), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Foshan Kycare Medical Equipment Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on December 29, 2025, 224 days after receiving the submission on May 19, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number	K251534 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2025
Decision Date	December 29, 2025
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF