Disposable Manual Resuscitator (NPVC-001/RTMA; NPVC-002/RTMA; NPVC-003/RTMA1)— 510(k) K263254

Name: FDA 510(k) clearance K263254
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Xiamen Compower Medical Tech. Co., Ltd.

FDA 510(k) clearance K263254 for Disposable Manual Resuscitator (NPVC-001/RTMA; NPVC-002/RTMA; NPVC-003/RTMA1), Substantially Equivalent on 2026-10-16. Applicant: Xiamen Compower Medical Tech. Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)
Applicant: Xiamen Compower Medical Tech. Co., Ltd.
Product code: Product code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2026-09-17
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTM

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K251631 — The BAG manual resuscitator and accessories2025-11-24
K243861 — butterflyBVM2025-04-25
K221841 — EOlife®2023-03-18
K212905 — Sotair Device2022-08-18
K210288 — Disposable Manual Resuscitator2021-08-26

More clearances from Xiamen Compower Medical Tech. Co., Ltd.

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K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)2017-11-17

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.