# K254171: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mericonn Technology Co., Ltd.
- Decided: Sep 18, 2026 after 269 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: 5 generations back to K923024 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230379: Portable (Ultrasonic) Nebulizer, Dongguan Simzo Electronic Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
The mesh nebulizer is an ultrasonic vibrating mesh nebulizer 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. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K254171
Methodology: https://510kreport.com/methodology