# K230379: Portable (Ultrasonic) Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Simzo Electronic Technology Co., Ltd.
- Decided: Nov 27, 2023 after 287 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: 4 generations back to K923024 (1992). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171549: Intelligent Mesh Nebulizer, Qingdao Future Medical Technology Co., Ltd. (2018) Summary page 6.

## Most influential descendants
- K254171: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (2026), 0 descendants of its own

## Indications for use
The portable (Ultrasonic) 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, schools, and long-term care facilities. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K230379
Methodology: https://510kreport.com/methodology