# K121154: Ultrasonic Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Gaunying Electronics Co., Ltd.
- Decided: Aug 20, 2012 after 126 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult patients at home, hospital & sub-acute care setting.

Source page: https://510kreport.com/device/K121154
Methodology: https://510kreport.com/methodology