# K170916: Portable Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Microbase Technology Corporation
- Decided: Nov 28, 2017 after 244 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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 4.

## Most influential descendants
- K180871: Portable Nebulizer (2018), 0 descendants of its own

## Indications for use
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.

Source page: https://510kreport.com/device/K170916
Methodology: https://510kreport.com/methodology