# K140211: Ultrasonic Mesh Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Foshan Gaunying Electronics Co., Ltd.
- Decided: May 30, 2014 after 122 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ultrasonic mesh nebulizer model NM21 IA 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/K140211
Methodology: https://510kreport.com/methodology