# K121520: Ultrasonic Nebulizer (Mesh Type)

- Pathway: 510(k) (Abbreviated)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Mar 15, 2013 after 297 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 Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.

Source page: https://510kreport.com/device/K121520
Methodology: https://510kreport.com/methodology