# K192971: Nebulizer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Excellentcare Medical (Huizhou), Ltd.
- Decided: Jul 8, 2021 after 624 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 K800562 (1980). 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)
- K800562: Disposable Hand Held Nebulizer, Intec Medical, Inc. (1980) Summary page 4.

## Indications for use
The Nebulizer kit is used to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways. The Nebulizer kit is intended for adult consistent with the indication for aerosol medication in hospitals and sub-acute institutions.

Source page: https://510kreport.com/device/K192971
Methodology: https://510kreport.com/methodology