# K923024: NE-U04/NE U04F

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Sep 15, 1992 after 84 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22 (2007), 19 descendants of its own
- K132247: Ultrasonic Mesh Nebulizer (2014), 6 descendants of its own
- K042991: I-Neb Aad System (2005), 6 descendants of its own
- K171549: Intelligent Mesh Nebulizer (2018), 5 descendants of its own
- K100380: Altera Nebulizer System, Model 678G1002 (2010), 4 descendants of its own

## Recalls of this device
- Nov 2, 2004 · Not classified · Z-0382-05: A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.

Source page: https://510kreport.com/device/K923024
Methodology: https://510kreport.com/methodology