Cleared Traditional

Westmed Gas Sampling Cannula with O2 delivery

K162343 · Westmed, Inc. · Anesthesiology
Dec 2016
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K162343 is an FDA 510(k) clearance for the Westmed Gas Sampling Cannula with O2 delivery, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on December 14, 2016, 114 days after receiving the submission on August 22, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K162343 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2016
Decision Date December 14, 2016
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

Similar Devices — CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 303
Medical Gas Analyzer (AG200)
K250148 · Prior Care Science Technology, Ltd. · Aug 2025
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
K243956 · Nihon Kohden Corporation · Jun 2025
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
K251216 · Barbaras Development, Inc. · Jun 2025
AIM (N/A)
K240937 · Inventeur, LLC · Dec 2024
AirLife? Open Et Oxygen Mask, AirLife? Open Et+ Oxygen Mask
K230915 · Vyaire Medical, Inc. · Nov 2024
MicroTrend System
K212425 · Exostat Medical, Inc. · Nov 2024