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The Tracker / October 2026 / K263254

510(k) cleared

Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)

Xiamen Compower Medical Tech. Co., Ltd. · Oct 16, 2026 · K263254

FDA cleared the Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) from Xiamen Compower Medical Tech. Co., Ltd. on Oct 16, 2026 under K263254, a special 510(k). The device falls under product code BTM, Ventilator, Emergency, Manual (Resuscitator), regulated at 21 CFR 868.5915 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 17, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xiamen Compower Medical Tech. Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K263254?

K263254 is the FDA 510(k) for Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1), submitted by Xiamen Compower Medical Tech. Co., Ltd.. FDA's decision date was Oct 16, 2026, under product code BTM (Ventilator, Emergency, Manual (Resuscitator)).

Who makes the Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)?

Xiamen Compower Medical Tech. Co., Ltd., based in Xiamen, is the applicant of record for K263254.

How long did the K263254 review take?

FDA received the submission on Sep 17, 2026 and issued its decision on Oct 16, 2026, 29 days later.

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