# K140113: O2 Nasal Cannula with CO2 Monitoring

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical, Ltd.
- Decided: Mar 6, 2014 after 50 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 K915228 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915228: Disposable CO2 Gas Sampling/Oxygen Delivery Cannul, Hospitak, Inc. (1992) Summary page 1.

## Indications for use
02 Nasal Cannula with C02 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and C02 monitoring

Source page: https://510kreport.com/device/K140113
Methodology: https://510kreport.com/methodology