# K042556: Shineball PVC Manual Resusciator, Ent-1001, Ent-1003, Ent-1005, Shineball Silicone Manual Resusciator, Ent-1022,

- Pathway: 510(k) (Traditional)
- Applicant: Enter Medical Corporation
- Decided: Mar 11, 2005 after 172 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: 1 generation back to K002846 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have 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 2.

## Indications for use
To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

Source page: https://510kreport.com/device/K042556
Methodology: https://510kreport.com/methodology