# K140237: Disposable Nebulizer Set

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Weikang Medical Apparatus Co., Ltd.
- Decided: Jan 8, 2015 after 343 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). 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)
- K121770: Headstar Medical Small Volume Jet Nebulizer, Headstar Medical Products Co., Ltd. (2013) Summary page 4.
- K926055: The Miller Nebulizer System, Warren C. Miller (1993) Summary page 4.

## Indications for use
The disposable nebulizer set is used to administer various aerosol treatments to adult patients in hospital environments. It is not intended for transport use. The Disposable Nebulizer Set is for single use for less than 24 hours cumulative use.

Source page: https://510kreport.com/device/K140237
Methodology: https://510kreport.com/methodology