# K201167: AireHealth NebulizerTM

- Pathway: 510(k) (Traditional)
- Applicant: Airehealth, Inc.
- Decided: Dec 3, 2020 after 216 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 K142541 (2016). 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)
- K142541: Pocket Neb, Microvaper Devices (2016) Summary page 5.

## Indications for use
The AireHealthTm Nebulizer electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The AireHealthTm Nebulizer may be used in adults or children 5 years of age and older. The AireHealthTM Nebulizer is a portable Nebulizer for use in and out of the home environment. The AireHealthTm Nebulizer is not intended as a life sustaining or life-supporting device. The AireHealthTm Nebulizer is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K201167
Methodology: https://510kreport.com/methodology