# K243861: butterflyBVM

- Pathway: 510(k) (Traditional)
- Applicant: Compact Medical, Inc.
- Decided: Apr 25, 2025 after 130 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: 2 generations back to K042843 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152931: Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator, Ambu A/S (2016) Summary page 5.

## Indications for use
The butterflyBVMTM when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates. The butterflyBVMTM when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.

Source page: https://510kreport.com/device/K243861
Methodology: https://510kreport.com/methodology