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.
306
Total
306
Cleared
147d
Avg days
1977
Since
Growing category -
8 submissions in the last 2 years
vs 5 in the prior period
Review times increasing: avg
344d
recently vs 142d historically
FDA 510(k) Cleared Analyzer, Gas, Carbon-dioxide, Gaseous-phase Devices (Product Code CCK)
306 devices
Cleared
May 01, 2026
Capnostream™35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC
Anesthesiology
224d
Cleared
Aug 28, 2025
Medical Gas Analyzer (AG200)
Prior Care Science Technology, Ltd.
Anesthesiology
219d
Cleared
Jun 10, 2025
TG-980P CO2 Sensor Kit (TG-980P)
Nihon Kohden Corporation
Anesthesiology
169d
Cleared
Jun 04, 2025
0184 CO2 Sampling line
Barbaras Development, Inc.
Anesthesiology
47d
Cleared
Dec 16, 2024
AIM (N/A)
Inventeur, LLC
Anesthesiology
255d
Cleared
Nov 12, 2024
AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
Vyaire Medical, Inc.
Anesthesiology
592d
Cleared
Nov 07, 2024
MicroTrend System
Exostat Medical, Inc.
Anesthesiology
1191d
Cleared
Nov 21, 2023
Oxy2Pro
Southmedic, Inc.
Anesthesiology
459d
Cleared
Sep 12, 2023
Endure ETCO2/02 Nasal Cannula
Endure Industries, Inc.
Anesthesiology
650d
Cleared
Apr 05, 2023
CO2 Mainstream Sensor
Draegerwerk AG & CO Kgaa
Anesthesiology
352d
Cleared
Jan 30, 2023
XChange Device, XChange System
Pneuma Therapeutics, Inc.
Anesthesiology
741d
Cleared
Nov 16, 2022
Endoscopy Oxygen Mask
Engineered Medical Systems, Inc.
Anesthesiology
265d
Cleared
Jul 29, 2022
Microstream CO2 NanoPod
Covidien, LLC
Anesthesiology
226d
Cleared
Apr 12, 2022
CARESCAPE CO2 Microstream parameter
Covidien, LLC
Anesthesiology
160d
Cleared
Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
GE Healthcare Finland Oy
Anesthesiology
185d
Cleared
Sep 17, 2021
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
Covidien
Anesthesiology
268d
Cleared
Mar 29, 2021
EMMA Capnograph
Masimo Corporation
Anesthesiology
290d
Cleared
Mar 04, 2021
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Unimed Medical Supplies, Inc.
Anesthesiology
59d
Cleared
May 22, 2020
CO2 Sidestream Module
Beijing Kingst Commercial & Trade Co., Ltd.
Anesthesiology
254d
Cleared
May 21, 2020
CO2 Mainstream Module
Beijing Kingst Commercial & Trade Co., Ltd.
Anesthesiology
258d
Cleared
Apr 27, 2020
Capnostream 35 Portable Respiratory Monitor
Oridion Medical 1987 , Ltd.
Anesthesiology
52d
Cleared
Jan 17, 2020
Altera gas Sampling Lines
Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology
122d
Cleared
Dec 18, 2019
Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric
Bluepoint Medical GmbH & Co. KG
Anesthesiology
261d
Cleared
May 23, 2019
MaxCap Ped and MaxCap Neo
Maxtec, LLC
Anesthesiology
266d
About Product Code CCK - Regulatory Context
510(k) Submission Activity
306 total 510(k) submissions under product code CCK since 1977, with 306 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - CCK Product Code
Recent submissions under CCK have taken an average of 344 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 →