# K933626: Capno-Flo

- Pathway: 510(k) (Traditional)
- Applicant: Kirk Specialty Systems
- Decided: Oct 6, 1993 after 82 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- 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
- K991955: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K933626
Methodology: https://510kreport.com/methodology