# K052811: Hsiner Jet Nebulizer, Model HS-31100

- Pathway: 510(k) (Traditional)
- Applicant: Hsiner Co., Ltd.
- Decided: Dec 21, 2005 after 78 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 K883964 (1988). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883964: Airlife Misty Neb Medication System W/Filter, Baxter Healthcare Corp (1988) Summary page 1.
- K884947: Hand Held Nebulizer System, Salter Labs (1989) Summary page 1.
- K930525: Micro Mist (TM) Nebulizer, Hudson Respiratory Care, Inc. (1993) Summary page 1.

## Most influential descendants
- K091272: Besmed Jet Nebulizer Bottle Set (2009), 1 descendant of its own
- K070948: Hsiner Nebulizer Bottle (2007), 1 descendant of its own
- K212395: Nebulizer (2022), 0 descendants of its own
- K082009: Hsiner Nebulizer Bottle, CPR Masks and Face Shields (2008), 0 descendants of its own

## Indications for use
The Hsiner Jet Nebulizer 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/K052811
Methodology: https://510kreport.com/methodology