# K072119: Airlife Nebulizer Cap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Aug 10, 2007 after 9 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
Longest line of descent: 2 generations back to K780406 (1978). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962161: Baxter Nebulizer Cap Model 2D0868, Baxter Healthcare Corp (1996) Summary page 1.
- K801251: Non-Conductive, Single Use Face Mask #55, Vital Signs, Inc. (1980) Summary page 1.

## Indications for use
The Nebulizer cap is for use with Sterile Water or Saline for Inhalation, USP in 500 ml, 1000 ml, and 1500 ml bottles for inhalation therapy only.

Source page: https://510kreport.com/device/K072119
Methodology: https://510kreport.com/methodology