# K250583: AdheResp Smart Breath-actuated Mesh Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Hcmed Innovations Co., Ltd.
- Decided: Jun 20, 2025 after 113 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: 3 generations back to K923024 (1992). 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)
- K202171: Pulmogine Vibrating Mesh Nebulizer, Hcmed Innovations Co., Ltd. (2021) Summary page 5.

## Indications for use
The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities

Source page: https://510kreport.com/device/K250583
Methodology: https://510kreport.com/methodology