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Capnoxygen Mask

by Medsys, Inc.

510(k) K971229

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971229 Date23 Sep 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Capnoxygen Mask is a medium-concentration oxygen mask designed for the delivery of supplemental oxygen. It features an integrated carbon dioxide sampling tube that allows for the simultaneous monitoring of exhaled gas via capnography.

This device is intended for single-use applications. It has received FDA 510(k) clearance under the classification of an analyzer for carbon dioxide in the gaseous phase.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Capnoxygen Mask?

    The Capnoxygen Mask is designed to deliver medium-concentration supplemental oxygen to a patient while simultaneously enabling the monitoring of exhaled carbon dioxide through an integrated sampling tube.

  • Is the Capnoxygen Mask intended for multiple uses?

    No, the Capnoxygen Mask is intended for single-use applications only. This ensures patient safety and prevents cross-contamination between clinical procedures.

  • What regulatory status does this device hold?

    The Capnoxygen Mask has received FDA 510(k) clearance under the classification of an analyzer for carbon dioxide in the gaseous phase, confirming it is substantially equivalent to legally marketed predicate devices.