# K002846: Headstar's Manual Emergency Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Headstar Medical Products Co., Ltd.
- Decided: Jun 6, 2001 after 267 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K053466: Hsiner Resuscitator (2006), 0 descendants of its own
- K042556: Shineball PVC Manual Resusciator, Ent-1001, Ent-1003, Ent-1005, Shineball Silicone Manual Resusciator, Ent-1022, (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K002846
Methodology: https://510kreport.com/methodology