# K082009: Hsiner Nebulizer Bottle, CPR Masks and Face Shields

- Pathway: 510(k) (Special)
- Applicant: Hsiner Co., Ltd.
- Decided: Aug 22, 2008 after 30 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: 3 generations back to K883964 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052811: Hsiner Jet Nebulizer, Model HS-31100, Hsiner Co., Ltd. (2005)
- K070948: Hsiner Nebulizer Bottle, Hsiner (2007) Summary page 1.

## Indications for use
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Source page: https://510kreport.com/device/K082009
Methodology: https://510kreport.com/methodology