# K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Feb 23, 2007 after 203 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: 1 generation back to K923024 (1992). 1 ancestor in all.
19 later devices descend from it; 12 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923024: NE-U04/NE U04F, Omron Healthcare, Inc. (1992) Summary page 1.

## Most influential descendants
- K132247: Ultrasonic Mesh Nebulizer (2014), 6 descendants of its own
- K171549: Intelligent Mesh Nebulizer (2018), 5 descendants of its own
- K230379: Portable (Ultrasonic) Nebulizer (2023), 1 descendant of its own
- K202171: Pulmogine Vibrating Mesh Nebulizer (2021), 1 descendant of its own
- K201397: Ultrasonic Mesh Nebulizer (2021), 1 descendant of its own

## Indications for use
The Omron NE-U22 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K062263
Methodology: https://510kreport.com/methodology