# K053142: Ambu Mark IV Baby Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Dec 20, 2005 after 41 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ambu® Silicone Resuscitator, Infant/Child: named in the summary without a submission number
- (no number) Ambu® Baby R, Resuscitator model R: named in the summary without a submission number
- (no number) Ambu® SPUR® II Infant: named in the summary without a submission number

## Most influential descendants
- K132172: Neonatalie Resuscitator (2015), 0 descendants of its own
- K102824: Ambu Oval Silicone Resuscitator, Adult and Pediatric (2011), 0 descendants of its own

## Indications for use
Ambu® Mark IV Baby Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of neonate, infants and children with a body weight up to 44 lbs (20 kg), approx. 4-5 years of age. Ambu® Mark IV Baby Resuscitator is a reusable resuscitator.

Source page: https://510kreport.com/device/K053142
Methodology: https://510kreport.com/methodology