# K121770: Headstar Medical Small Volume Jet Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Headstar Medical Products Co., Ltd.
- Decided: Apr 17, 2013 after 306 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140237: Disposable Nebulizer Set (2015), 0 descendants of its own

## Indications for use
The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use. Based on practical measurement and comparison, Headstar Medical Small Volume Jet Nebulizer is intended for following populations: HP-2557 Nebulizer with child face mask: 2-9 years old pediatric patients HP-2558 Nebulizer with adult face mask: for adult patients HP-2290 Nebulizer with mouth piece &02 tubing: pediatric over 5 years and adult patients HP-2291 Nebulizer with mouth/T piece & hoselO2 tubing: pediatric over 5 years and adult patients The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e.; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.

Source page: https://510kreport.com/device/K121770
Methodology: https://510kreport.com/methodology