# K112041: Koo Small Volume Nebulizer (SVN)

- Pathway: 510(k) (Traditional)
- Applicant: Koo (Shanghai) Industries Co., Ltd.
- Decided: Dec 22, 2011 after 157 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 K926055 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926055: The Miller Nebulizer System, Warren C. Miller (1993) Summary page 1.

## Indications for use
The Koo SVN is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. The Koo SVN is intended for use with pediatric (defined by the prescribed medication) and adult patients consistent with the indications for the aerosol medication. This includes hospital/institutional settings, home care use, schools and long term care facilities.

Source page: https://510kreport.com/device/K112041
Methodology: https://510kreport.com/methodology