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 Datex Division Instrumentarium Corp., Nihon Kohden America, Inc. and Salter Labs.