# K123527: Airlife

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Apr 25, 2013 after 160 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 K870027 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K962879: Salterlabs 8660 Series Nebulizer, Salter Labs (1996) Summary page 1.

## Most influential descendants
- K230602: Hudson RCI® TurboMist™ Nebulizer System (2023), 0 descendants of its own

## Indications for use
This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.

Source page: https://510kreport.com/device/K123527
Methodology: https://510kreport.com/methodology