# K102824: Ambu Oval Silicone Resuscitator, Adult and Pediatric

- Pathway: 510(k) (Abbreviated)
- Applicant: Ambu A/S
- Decided: Jan 28, 2011 after 121 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 K910040 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910040: Ambu Sir 2 (Silicone Resuscitator), Adult, Ambu, Inc. (1991) Summary page 1.
- K053140: Ambu Mark IV Resuscitator, Ambu A/S (2005) Summary page 3.
- K914187: Ambu Silicone Resuscitator Infant/Child, Ambu, Inc. (1991) Summary page 3.
- K053142: Ambu Mark IV Baby Resuscitator, Ambu A/S (2005) Summary page 3.

## Indications for use
The Ambu® Oval Silicone resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. For use by CPR-trained personnel only, in hospital and pre-hospital settings. The Ambu Oval Silicone resuscitator is reusable. The range of application for the sizes are: Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.). Paediatric: Infants and children with a body weight between approx. 10-30 kg (22-66 lbs.)

Source page: https://510kreport.com/device/K102824
Methodology: https://510kreport.com/methodology