# K162343: Westmed Gas Sampling Cannula with O2 delivery

- Pathway: 510(k) (Traditional)
- Applicant: Westmed, Inc.
- Decided: Dec 14, 2016 after 114 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
The Westmed nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases. Cumulative duration of use < 24 hours. Environment of use: Hospital, sub-acute, and pre-hospital settings Patient population: Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics (> 10 kg.).

Source page: https://510kreport.com/device/K162343
Methodology: https://510kreport.com/methodology