# K153748: AirLife Misty Finity Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: May 17, 2017 after 505 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 K943600 (1994). 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)
- K943600: Uniheart, Vortran Medical Technology 1, Inc. (1994) Summary page 4.

## Indications for use
The Misty Finity is a nebulizer designed for administration of aerosolized drug to the respiratory system. Misty Finity may be used with pediatric (ages 2 years and above) and adult patients. The product is single patient use device, non-sterile and used in professional healthcare environments under a doctor’s supervision and by skilled clinician.

Source page: https://510kreport.com/device/K153748
Methodology: https://510kreport.com/methodology