# K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector

- Pathway: 510(k) (Traditional)
- Applicant: Fenem, Inc.
- Decided: Jul 20, 1989 after 43 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, 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
- K021576: Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370 (2002), 4 descendants of its own
- K133540: Flocap (2014), 1 descendant of its own
- K042572: Kendall CO2NFIRM Now CO2 Detector (2004), 1 descendant of its own

Source page: https://510kreport.com/device/K894053
Methodology: https://510kreport.com/methodology