# K112840: Capnodura Combi & Capnodura Pedi CO2 Detector

- Pathway: 510(k) (Traditional)
- Applicant: Seebreath AB
- Decided: Jul 13, 2012 after 288 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031411: Mini STATCO2 CO2 Detector, Model 10-55371, Mercury Medical (2003) Summary page 2.
- K021576: Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370, Mercury Medical (2002) Summary page 2.

## Indications for use
CapnoDura Pedi: To provide a semi quantitative visualization of the C02 in the patient airway. This device is to be used on patient weighing 1 kg - 15 kg. 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. To assist verification of tracheal tube placement inthe trachea following intubation and to observe respiration by the detector's color changes. CapnoDura Combi: To provide a semi quantitative visualization of the C02 in the patient airway. This device is to be used on patient weighing 10 kg or above. 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. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detectors color changes.

Source page: https://510kreport.com/device/K112840
Methodology: https://510kreport.com/methodology