# K924610: Baxter Adult/Pedi/Infant Single Use Man Resuscit

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Apr 6, 1993 after 207 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K993194: Rusch Manual Resuscitator Bag (2000), 0 descendants of its own
- K991955: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection (1999), 0 descendants of its own
- K991953: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection (1999), 0 descendants of its own

## Recalls of this device
- Apr 22, 2013 · Class II · Z-1947-2013: CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag 

Source page: https://510kreport.com/device/K924610
Methodology: https://510kreport.com/methodology