# K182956: Puffin Lite Infant Resuscitation System

- Pathway: 510(k) (Special)
- Applicant: International Biomedical
- Decided: Jan 18, 2019 after 86 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K760102 (1976). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140707: Lifeborne Infant Resuscitator, International Biomedical (2014) Summary page 4.

## Indications for use
The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

Source page: https://510kreport.com/device/K182956
Methodology: https://510kreport.com/methodology