# K152931: Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

- Pathway: 510(k) (Abbreviated)
- Applicant: Ambu A/S
- Decided: Aug 29, 2016 after 329 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042843 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042682: Ambu Spur II. Adult Single Patient Resuscitator, Ambu, Inc. (2004) Summary page 5.
- K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators, Ambu, Inc. (2004) Summary page 5.

## Most influential descendants
- K243861: butterflyBVM (2025), 0 descendants of its own

## Recalls of this device
- Jul 9, 2025 · Class I · Z-2181-2025: Potential for the manometer port being blocked rendering the manometer non-functional.

## Indications for use
The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation. The range of the application for each version is: - Adult: Adults and children with a body weight more than 30kg (66lb). - Pediatric: Infant and children with a body weight up to 30kg (66lb). - Infant: Neonates and infant with a body weight up to 10kg (22lb).

Source page: https://510kreport.com/device/K152931
Methodology: https://510kreport.com/methodology