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.
FDA 510(k) Cleared Analyzer, Gas, Carbon-dioxide, Gaseous-phase Devices (Product Code CCK)
About Product Code CCK - Regulatory Context
510(k) Submission Activity
305 total 510(k) submissions under product code CCK since 1977, with 305 receiving FDA clearance (average review time: 148 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under CCK have taken an average of 385 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
CCK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →