FDA Product Code CCK: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Under FDA product code CCK, gaseous-phase carbon dioxide analyzers are cleared for continuous capnography during anesthesia and critical care.
These devices measure end-tidal CO2 concentration in exhaled gas to confirm endotracheal tube placement, monitor ventilation adequacy, and detect respiratory compromise. Capnography is now a standard of care during general anesthesia and procedural sedation.
CCK devices are Class II medical devices, regulated under 21 CFR 868.1400 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Covidien, LLC, Masimo Corporation and Covidien.
List of Analyzer, Gas, Carbon-dioxide, Gaseous-phase devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Analyzer, Gas, Carbon-dioxide, Gaseous-phase devices (product code CCK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →