# K021576: Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Medical
- Decided: Nov 4, 2002 after 174 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
Longest line of descent: 1 generation back to K894053 (1989). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector, Fenem, Inc. (1989) Summary page 1.

## Most influential descendants
- K133540: Flocap (2014), 1 descendant of its own
- K261633: VisuBreath (2026), 0 descendants of its own
- K112840: Capnodura Combi & Capnodura Pedi CO2 Detector (2012), 0 descendants of its own
- K031814: STATCO2METER, Model 10-55372 (2003), 0 descendants of its own

## Indications for use
The Mercury Medical STATC02m' End Tidal C02 Detector is to provide a semi-quantitative visualization of the C02 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

Source page: https://510kreport.com/device/K021576
Methodology: https://510kreport.com/methodology