# K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Nov 12, 2004 after 29 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152931: Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator (2016), 1 descendant of its own
- K243861: butterflyBVM (2025), 0 descendants of its own
- K181583: Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 (2018), 0 descendants of its own
- K094003: Revivator (2010), 0 descendants of its own

## Recalls of this device
- Mar 7, 2014 · Class II · Z-2086-2014: The femoral stem is lacking specified plasma coating.

## Indications for use
The Arnbu SPUR Ill Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 221bs (10kg). The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 661bs (30kg), approx. 9 years of age.

Source page: https://510kreport.com/device/K042843
Methodology: https://510kreport.com/methodology