# K120518: End Tidal CO2 Nasal Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: May 4, 2012 after 73 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 K863883 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863883: Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula, Salter Labs (1986) Summary page 1.
- K892406: Modified Oxygen Delivery/CO2 Sample Nasal Cannula, Salter Labs (1989) Summary page 1.

## Indications for use
The ETC0 2 Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen, up to 4 Ulmin, to a patient while providing a means to sample expired gas- The target population is adult and pediatric patients.

Source page: https://510kreport.com/device/K120518
Methodology: https://510kreport.com/methodology