# K053466: Hsiner Resuscitator

- Pathway: 510(k) (Abbreviated)
- Applicant: Hsiner Co., Ltd.
- Decided: Mar 22, 2006 after 99 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923976 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002846: Headstar's Manual Emergency Resuscitator, Headstar Medical Products Co., Ltd. (2001) Summary page 1.
- K012842: V*Care Manual Resuscitator, Ventlab Corp. (2001)
- K944301: Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380, Hudson Respiratory Care, Inc. (1994) Summary page 1.
- K923976: Ambu Single Patient Use Peep Valve, Ambu, Inc. (1993) Summary page 1.
- K902062: Peep Valve, Hudson Oxygen Therapy Sales Co. (1990) Summary page 1.
- K983920: Ems Peep Valves- Adjustable, Engineered Medical Systems (1999) Summary page 1.

## Indications for use
The Hsiner PEEP Valve is used in conjunction vith manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.

Source page: https://510kreport.com/device/K053466
Methodology: https://510kreport.com/methodology