# K132247: Ultrasonic Mesh Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Gaunying Electronics Co., Ltd.
- Decided: Jan 8, 2014 after 173 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.
6 later devices descend from it; 1 cites it directly.
0 of 9 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 1.

## Most influential descendants
- K171549: Intelligent Mesh Nebulizer (2018), 5 descendants of its own
- K230379: Portable (Ultrasonic) Nebulizer (2023), 1 descendant of its own
- K201397: Ultrasonic Mesh Nebulizer (2021), 1 descendant of its own
- K254171: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (2026), 0 descendants of its own
- K251659: Mesh Nebulizer (H6) (2025), 0 descendants of its own

## Indications for use
The ultrasonic mesh nebulizer model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.

Source page: https://510kreport.com/device/K132247
Methodology: https://510kreport.com/methodology