# K943617: Disposable Manual Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Puritan-Bennett
- Decided: Aug 11, 1994 after 15 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.
7 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960468: DMR/CO2 Combo Kti (1996), 6 descendants of its own
- K973419: DMR Plus Disposable Manual Resuscitator (1998), 5 descendants of its own
- K021328: Smart Bag MO (2003), 1 descendant of its own
- K212905: Sotair Device (2022), 0 descendants of its own
- K023494: Nellcor Indgo Manual Resuscitator (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K943617
Methodology: https://510kreport.com/methodology