# K091794: CARE2 Medical Nebulizer, Model 101/102, 201/202

- Pathway: 510(k) (Traditional)
- Applicant: Steve Islava
- Decided: Jan 28, 2010 after 225 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 K760489 (1976). 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)
- K760489: Nebulizer, Handheld (T UP-Draft), Hudson Oxygen Therapy Sales Co. (1976) Summary page 1.
- K926055: The Miller Nebulizer System, Warren C. Miller (1993) Summary page 1.
- K023602: Small Volume Nebulizer, Allegiance Healthcare Corporation (2003) Summary page 2.

## Indications for use
The Care2 Medical Nebulizer is a pneumatic nebulizer intended to aerosolize physician prescribed inhalation solutions for inhalation by infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes inhalation solutions to a patient using a small volume nebulizer. The device is single patient use.

Source page: https://510kreport.com/device/K091794
Methodology: https://510kreport.com/methodology