# K051226: Airlife Nasal Continuous Positive Airway Pressure (Ncpap) Sytem Driver

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Nov 17, 2005 after 189 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 2 (0 Class I)
- 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 Driver: named in the summary without a submission number

## Recalls of this device
- Jan 4, 2008 · Not classified · Z-0987-2008: Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxillary port on the driver is used as a blender in administering O2
- Jun 1, 2007 · Not classified · Z-1075-2007: Under isolated conditions, the device may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance.

## Indications for use
The AirLifeTM Nasal Continuous Positive Airway Pressure (nCPAP) System Driver is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or are recovering from RDS.

Source page: https://510kreport.com/device/K051226
Methodology: https://510kreport.com/methodology