Cleared Traditional

Disposable Manual Resuscitator

K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology
Aug 2021
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K210288 is an FDA 510(k) clearance for the Disposable Manual Resuscitator, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Xiamen Compower Medical Tech. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on August 26, 2021, 205 days after receiving the submission on February 2, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K210288 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2021
Decision Date August 26, 2021
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

Similar Devices — BTM Ventilator, Emergency, Manual (resuscitator)

All 208
The BAG manual resuscitator and accessories
K251631 · Laerdal Medical AS · Nov 2025
butterflyBVM
K243861 · Compact Medical, Inc. · Apr 2025
EOlife?
K221841 · Archeon · Mar 2023
Sotair Device
K212905 · Safe Bvm Corporation · Aug 2022
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583 · Flexicare Medical Limited. · Dec 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663 · Foremount Enterprise Co., Ltd. · May 2018