# K133105: Breeze Nebulizer (NBR-10X)

- Pathway: 510(k) (Traditional)
- Applicant: Digio2 International Co., Ltd.
- Decided: Jun 24, 2014 after 267 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 Breeze Nebulizer (NBR-l0l) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (ages 2 years old and above) and adult patients in the home. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K133105
Methodology: https://510kreport.com/methodology