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Capnocheck Plus

by Bci Intl., Inc. 510(k)

Active United States

510(k) K970209

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970209 Date18 Apr 1997ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1014-2013 FDA Class I initiated 6 Feb 2013

    In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.

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 Capnocheck Plus is a capnograph that measures respiratory gas CO2 levels, suitable for use as a stand-alone, bedside, or transport device with oximeter option. It combines End Tidal CO2 technology with the flexibility to add pulse oximetry and FiO2 as needed. The device reliably monitors either intubated or non-intubated patients.

The Capnocheck Plus is supplied as a portable monitor and is used in situations where respiratory monitoring is required, such as for mechanically ventilated patients or individuals receiving PCA analgesia. The device has received FDA 510K authorization and is classified under product code CCK.

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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 Capnocheck Plus used for?

    The Capnocheck Plus is used to measure respiratory gas CO2 levels in patients, particularly in situations where respiratory monitoring is required, such as for mechanically ventilated patients or individuals receiving PCA analgesia.

  • Is the Capnocheck Plus portable?

    Yes, the Capnocheck Plus is supplied as a portable monitor, making it suitable for use in various settings, including bedside or transport.

  • Can the Capnocheck Plus be used for both intubated and non-intubated patients?

    Yes, the device reliably monitors either intubated or non-intubated patients, providing flexibility in its application.

  • What additional features can be added to the Capnocheck Plus?

    The Capnocheck Plus has the flexibility to add pulse oximetry and FiO2 as needed, in addition to its End Tidal CO2 technology.