# K210288: Disposable Manual Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Compower Medical Tech. Co., Ltd.
- Decided: Aug 26, 2021 after 205 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902062 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170663: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer, Foremount Enterprise Co., Ltd. (2018) Summary page 5.

## Indications for use
Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg

Source page: https://510kreport.com/device/K210288
Methodology: https://510kreport.com/methodology