# K140707: Lifeborne Infant Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: International Biomedical
- Decided: May 28, 2014 after 69 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: 3 generations back to K760102 (1976). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070210: Giraffe and Panda  T- Piece Resuscitation System, Ohmeda Medical (2007) Summary page 1.
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 1.

## Most influential descendants
- K182956: Puffin Lite Infant Resuscitation System (2019), 0 descendants of its own

## Indications for use
The LifeBorne 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/K140707
Methodology: https://510kreport.com/methodology