# K031814: STATCO2METER, Model 10-55372

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Medical
- Decided: Aug 14, 2003 after 63 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: 2 generations back to K894053 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021576: Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370, Mercury Medical (2002) Summary page 1.
- K954486: Mercury Airway Pressure Manometer, Mercury Medical (1996) Summary page 1.

## Indications for use
The Mercury Medical StatC02meterTM End Tidal C02 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the C02 in the patient airway while measuring Airway and PEEP pressure. 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/K031814
Methodology: https://510kreport.com/methodology