# K982722: Ambu Medibag Adult, Ambu Medibag Infant/Child

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Apr 12, 1999 after 250 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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.

## Indications for use
The Ambu MediBag Adult Resuscitator is intended for pulmonary resuscitation of adult patients with a body weight of more than 66 Ibs (30 kg) and for administration of inhaled B-adrenergic agonist for emergency patients in acute asthma. The resuscitator meets the requirements of the ASTM F920-93 standard except the operation temperature range which is limited to +32 degree - +122 Degree F (0 degree - 50 degree C).

Source page: https://510kreport.com/device/K982722
Methodology: https://510kreport.com/methodology