# K023602: Small Volume Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corporation
- Decided: May 1, 2003 after 185 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
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices 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) Airlife Misty-Neb Nebulizer: named in the summary without a submission number

## Most influential descendants
- K060399: LC Sprint Nebulizer (2006), 3 descendants of its own
- K123527: Airlife (2013), 1 descendant of its own
- K230602: Hudson RCI® TurboMist™ Nebulizer System (2023), 0 descendants of its own
- K092560: Pari Sinus (2010), 0 descendants of its own
- K091794: CARE2 Medical Nebulizer, Model 101/102, 201/202 (2010), 0 descendants of its own

## Indications for use
The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physicidn or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.

Source page: https://510kreport.com/device/K023602
Methodology: https://510kreport.com/methodology