# K132172: Neonatalie Resuscitator

- Pathway: 510(k) (Abbreviated)
- Applicant: Laerdal Medical A/S
- Decided: Jan 15, 2015 after 549 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 K053142 (2005). 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)
- K053142: Ambu Mark IV Baby Resuscitator, Ambu A/S (2005) Summary page 4.

## Indications for use
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.

Source page: https://510kreport.com/device/K132172
Methodology: https://510kreport.com/methodology