# K031411: Mini STATCO2 CO2 Detector, Model 10-55371

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Medical
- Decided: Jul 30, 2003 after 86 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 K944400 (1994). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944400: Pedi-Cap, Nellcor, Inc. (1994) Summary page 1.

## Most influential descendants
- K083056: Neo-Stat CO2 <KG (2009), 1 descendant of its own
- K182362: MaxCap Ped and MaxCap Neo (2019), 0 descendants of its own
- K112840: Capnodura Combi & Capnodura Pedi CO2 Detector (2012), 0 descendants of its own

## Indications for use
The Mercury Medical Mini StatCO2TM End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 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/K031411
Methodology: https://510kreport.com/methodology