# K093081: Pocket BVM

- Pathway: 510(k) (Traditional)
- Applicant: Microbvm Systems, Ltd.
- Decided: Feb 5, 2010 after 127 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: 1 generation back to K042682 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042682: Ambu Spur II. Adult Single Patient Resuscitator, Ambu, Inc. (2004) Summary page 1.

## Indications for use
The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.

Source page: https://510kreport.com/device/K093081
Methodology: https://510kreport.com/methodology