Capnomed

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

510(k) Number

K851658 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Narkomed MRI Anesthesia System

  Class II

  FDA 510(k) K972848 Active Cleared 30 Oct 1997

• Spectramed Respiratory Gas Analyzer

  Class II

  FDA 510(k) K873194 Active Cleared 30 Oct 1987

• Evite Xl

  Class II

  FDA 510(k) K083050 Active Cleared 29 Dec 2008

• Vapor 19

  Class II

  FDA 510(k) K771899 Active Cleared 18 Oct 1977

• Nbp Cuff

  Class II

  FDA 510(k) K092999 Active Cleared 24 Nov 2009

• Narkomed 6000 Model Number NM6000

  Class II

  FDA 510(k) K980553 Active Cleared 4 Aug 1998

See all devices from Draeger Medical, Inc. →

• What clinical settings is the Capnomed CO₂ Capnometer primarily designed for, and why is it useful in those environments?

  The Capnomed CO₂ Capnometer is designed for use in clinical settings like operating rooms, intensive care units, and emergency departments. It provides real-time measurement of exhaled carbon dioxide (CO₂) concentrations, which is critical for monitoring ventilation and respiratory function during anesthesia or critical care. This ensures accurate assessment of a patient’s breathing and helps clinicians quickly identify issues like hypoventilation or disconnection from the ventilator.

• Is the Capnomed CO₂ Capnometer a single-use or reusable device, and what maintenance is required?

  The Capnomed CO₂ Capnometer is a reusable medical instrument. Since it is intended for repeated use, it requires proper calibration and maintenance as outlined by the manufacturer to ensure consistent accuracy and reliability. Regular upkeep is essential to maintain its performance in clinical settings.

• How was the Capnomed CO₂ Capnometer evaluated for regulatory approval in the U.S., and what does that mean for its use?

  The Capnomed CO₂ Capnometer was authorized for use in the United States through an FDA 510(k) clearance process, specifically under the traditional review pathway. The device was determined to be substantially equivalent to a legally marketed predicate device, as reviewed by the Anesthesiology Advisory Committee. This means it meets regulatory standards for respiratory monitoring equipment and is considered safe and effective for its intended use in clinical practice.

• What type of respiratory monitoring does the Capnomed CO₂ Capnometer provide, and why is this feature important?

  The Capnomed CO₂ Capnometer provides capnography monitoring, which measures and displays exhaled carbon dioxide (CO₂) concentrations in real time. This feature is important because it allows clinicians to assess ventilation efficiency, detect respiratory issues like apnea or hypoventilation, and ensure proper endotracheal tube placement during procedures such as anesthesia or mechanical ventilation.