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Westmed Gas Sampling Cannula with O2 delivery

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162343

by Westmed, Inc.

Identifiers

510(k) Number
K162343 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Westmed Gas Sampling Cannula with O2 delivery is a disposable, single-patient-use device designed to deliver supplemental oxygen while simultaneously sampling expired gases for monitoring. It features nasal prongs for insertion into the nostrils and is intended for use in capnography applications to monitor respiratory status.

The device is supplied sterile and is intended for single-use only. It is authorized under FDA 510(k) clearance (K162343) with product code CCK and is classified under the Anesthesiology advisory committee. The device is manufactured by Westmed, Inc. and is not indicated for MRI safety or reuse.

Frequently asked questions

What is the Westmed Gas Sampling Cannula with O2 delivery used for?

It is designed to deliver supplemental oxygen while simultaneously sampling expired gases for monitoring respiratory status in capnography applications, allowing clinicians to assess ventilation and oxygenation during procedures.

Is the Westmed Gas Sampling Cannula with O2 delivery sterile and intended for single-use only?

Yes, the device is supplied sterile and is explicitly intended for single-patient-use only, as stated in the device data, to prevent cross-contamination and ensure patient safety during respiratory monitoring.

What regulatory authorization does the Westmed Gas Sampling Cannula with O2 delivery have?

The device is authorized under FDA 510(k) clearance (K162343) with product code CCK and was reviewed by the Anesthesiology advisory committee, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Westmed Cannulas and Mask Manufacturer - Mercury Medical, Westmed Gas Sampling Cannula with O2 delivery, Westmed CO2 Sampling Nasal Cannulas | Medline Industries, Inc., Westmed CO2 Sampling Nasal Cannulas - CO2 Sampling Nasal Cannula with ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Westmed, Inc.

Sources (1)

  • FDA 510(k) K162343 24 fields · synced Sep 21, 2026