CCK · Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Anesthesiology · 21 CFR 868.1400 · Class 2
Overview
| Product Code | CCK |
|---|---|
| Device Name | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 304)
Showing 20 most recent of 304 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | Aug 28, 2025 | SESE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | Jun 10, 2025 | SESE |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | Jun 4, 2025 | SESE |
| K240937 | AIM (N/A) | Inventeur, LLC | Dec 16, 2024 | SESE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | Vyaire Medical, Inc. | Nov 12, 2024 | SESE |
| K212425 | MicroTrend System | Exostat Medical, Inc. | Nov 7, 2024 | SESE |
| K222511 | Oxy2Pro | Southmedic, Inc. | Nov 21, 2023 | SESE |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | Sep 12, 2023 | SESE |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | Apr 5, 2023 | SESE |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | Jan 30, 2023 | SESE |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | Nov 16, 2022 | SESE |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | Jul 29, 2022 | SESE |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | Apr 12, 2022 | SESE |
| K211171 | 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 | Oct 21, 2021 | SESE |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | Covidien | Sep 17, 2021 | SESE |
| K201590 | EMMA Capnograph | Masimo Corporation | Mar 29, 2021 | SESE |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ | Unimed Medical Supplies, Inc. | Mar 4, 2021 | SESE |
| K192488 | CO2 Sidestream Module | Beijing Kingst Commercial & Trade Co., Ltd. | May 22, 2020 | SESE |
| K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | May 21, 2020 | SESE |
| K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | Apr 27, 2020 | SESE |
Top Applicants
- Oridion Medical 1987 , Ltd. — 17 clearances
- Datex Division Instrumentarium Corp. — 9 clearances
- Nihon Kohden America, Inc. — 9 clearances
- Salter Labs — 8 clearances
- Biochem International, Inc. — 6 clearances
