# K060497: Babyair

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Jul 11, 2006 after 137 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: 1 generation back to K023602 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023602: Small Volume Nebulizer, Allegiance Healthcare Corporation (2003) Summary page 1.

## Indications for use
The BabyAirTM is a pneumatic nebulizer, UDN, with a hood, which nebulizes specific drugs for inhalation by a patient. The patient population includes infants. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a nebulizer. This product is a single patient, multi-use, non-sterile prescriptive device. It is intended to be used in either a hospital or homecare environment.

Source page: https://510kreport.com/device/K060497
Methodology: https://510kreport.com/methodology