# K202171: Pulmogine Vibrating Mesh Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Hcmed Innovations Co., Ltd.
- Decided: Jul 1, 2021 after 332 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: 2 generations back to K923024 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22, Omron Healthcare, Inc. (2007) Summary page 4.

## Most influential descendants
- K250583: AdheResp Smart Breath-actuated Mesh Nebulizer (2025), 0 descendants of its own

## Indications for use
The Pulmogine@ Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities.

Source page: https://510kreport.com/device/K202171
Methodology: https://510kreport.com/methodology