C-CO2 Colorimetric CO2 Indicator

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

510(k) Number

K050066 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Circuit Breathing

  Class I

  FDA 510(k) K840740 Active Cleared 17 Apr 1984

• Dispos. Anesthesia Face Mask

  Class I

  FDA 510(k) K840535 Active Cleared 21 Feb 1984

• Disposable Non-Rebreathing Anes. Circuit

  Class I

  FDA 510(k) K823714 Active Cleared 7 Jan 1983

• Marquest Sct 2000, Heated Humidification System

  Class II

  FDA 510(k) K880979 Active Cleared 15 Jul 1988

• Disposable Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K822379 Active Cleared 20 Aug 1982

• Temp Marq Convective Warming System

  Class II

  FDA 510(k) K904690 Active Cleared 1 Feb 1991

See all devices from Marquest Medical Products, Inc. →

• What is the C-CO2 Colorimetric CO2 Indicator used for?

  The C-CO2 Colorimetric CO2 Indicator is used as an adjunct to clinical assessment to help verify correct endotracheal tube placement by providing a semi-quantitative visualization of carbon dioxide in the patient's exhaled gas or airway.

• How is the C-CO2 Colorimetric CO2 Indicator supplied and is it reusable?

  The device is supplied by Marquest Medical Products, Inc. and is intended for single-use only; it is not designed for cleaning, sterilization, or reuse due to its colorimetric chemical indicator mechanism that changes upon exposure to CO2.

• What regulatory pathway was used for the C-CO2 Colorimetric CO2 Indicator?

  The C-CO2 Colorimetric CO2 Indicator received FDA 510(k) clearance under submission number K050066, demonstrating substantial equivalence to a legally marketed predicate device.