# K213767: Endure ETCO2/02 Nasal Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Endure Industries, Inc.
- Decided: Sep 12, 2023 after 650 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 K010024 (2001). 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)
- K010024: O2/CO2 Nasal Filterline, Oridion Medical 1987, Ltd. (2001) Summary page 4.

## Indications for use
Endure ETCO2/O2 Nasal Cannula has two functions 1) It is intended to deliver supplemental Oxygen to patients and 2) to obtain CO2 sampling of exhaled air Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers. Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.

Source page: https://510kreport.com/device/K213767
Methodology: https://510kreport.com/methodology