# K050994: Airlife Infant Nasal Continuous Positive Airway Pressure System

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Aug 3, 2005 after 106 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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. The FDA summary names its predicate without a number.
- (no number) EME Infant Flow System: named in the summary without a submission number

## Indications for use
This device, consisting of a generator, prongs, masks and a headgear/fixation device is intended to provide continuous positive airway pressure to newborns and infants with compromised respiratory systems while in a hospital environment.

Source page: https://510kreport.com/device/K050994
Methodology: https://510kreport.com/methodology