ClearanceBrief
Panels › Anesthesiology › Product code CCK · Class 2

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Regulation 868.1400

3510(k)s in 12 months (307 all time)
0recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in CCK

Decided510(k)Device and applicantCode
Aug 12, 2026K251641GF-310R Multigas Unit (GF-310R)
Nihon Kohden Corporation, JP
CCK
Jul 14, 2026K261633VisuBreath
Affirm Medical Technologies II, LLC
CCK
May 1, 2026K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC
CCK
Aug 28, 2025K250148Medical Gas Analyzer (AG200)
Prior Care Science Technology, Ltd., CN
CCK
Jun 10, 2025K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
Nihon Kohden Corporation, JP
CCK
Jun 4, 2025K2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
Barbaras Development, Inc.
CCK
Dec 16, 2024K240937AIM (N/A)
Inventeur, LLC
CCK
Nov 12, 2024K230915AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
Vyaire Medical, Inc.
CCK
Nov 7, 2024K212425MicroTrend System
Exostat Medical, Inc.
CCK
Nov 21, 2023K222511Oxy2Pro
Southmedic, Inc., CA
CCK
Sep 12, 2023K213767Endure ETCO2/02 Nasal Cannula
Endure Industries, Inc.
CCK
Apr 5, 2023K221118CO2 Mainstream Sensor
Draegerwerk AG & CO Kgaa, DE
CCK
Jan 30, 2023K210112XChange Device, XChange System
Pneuma Therapeutics, Inc.
CCK
Nov 16, 2022K220533Endoscopy Oxygen Mask
Engineered Medical Systems, Inc.
CCK
Jul 29, 2022K213911Microstream CO2 NanoPod
Covidien, LLC
CCK
Apr 12, 2022K213518CARESCAPE CO2 Microstream parameter
Covidien, LLC
CCK
Oct 21, 2021K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
GE Healthcare Finland Oy, FI
CCK
Sep 17, 2021K203762Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
Covidien
CCK
Mar 29, 2021K201590EMMA Capnograph
Masimo Corporation
CCK
Mar 4, 2021K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Unimed Medical Supplies, Inc., CN
CCK
May 22, 2020K192488CO2 Sidestream Module
Beijing Kingst Commercial & Trade Co., Ltd., CN
CCK
May 21, 2020K192446CO2 Mainstream Module
Beijing Kingst Commercial & Trade Co., Ltd., CN
CCK
Apr 27, 2020K200594Capnostream 35 Portable Respiratory Monitor
Oridion Medical 1987 , Ltd., IL
CCK
Jan 17, 2020K192563Altera gas Sampling Lines
Meditera Tibbi Malzeme San VE Tic AS, TR
CCK
Dec 18, 2019K190824Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric
Bluepoint Medical GmbH & Co. KG, DE
CCK
May 23, 2019K182362MaxCap Ped and MaxCap Neo
Maxtec, LLC
CCK
May 1, 2019K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
GE Healthcare Finland Oy, FI
CCK
Mar 22, 2019K181624Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Li
Oridion Medical 1987 , Ltd., IL
CCK
Feb 8, 2019K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
Oridion Medical 1987 , Ltd., IL
CCK
Feb 6, 2019K181981CO2 Sampling Line
Tylenol Medical Instruments Co., Ltd., CN
CCK
Jan 11, 2019K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
Medipines Corporation
CCK
Jul 18, 2018K170820Capnograph and Oximeter
Cmi Health, Inc.
CCK
Jun 20, 2018K173147SuperNO2VA Et Device
Revolutionary Medical Devices, Inc.
CCK
May 31, 2018K171828ETCO2 Sensor
Orantech, Inc., CN
CCK
Apr 30, 2018K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft,
Vyaire Medical, Inc., FI
CCK
Apr 19, 2018K172365Panoramic Oxygen Mask (POM)
Pom Medical, LLC
CCK
Jan 4, 2018K171235OmniCap
Respirion, Inc.
CCK
Dec 26, 2017K172904IntelliVue Capnography Extension, IntelliVue Microstream Extension
Philips Medizin Systeme Boeblingen GmbH, DE
CCK
Oct 11, 2017K171765Nihon Kohden CO2 Monitor
Nihon Kohden Corporation, JP
CCK
Aug 17, 2017K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
GE Healthcare Finland Oy, FI
CCK
Mar 17, 2017K161250OC-FLEX Flexible IntraOral Cannula
Venture Therapeutics, Inc.
CCK
Feb 24, 2017K161860TG-970P CO2 Sensor Kit
Nihon Kohden Corporation, JP
CCK
Dec 14, 2016K162343Westmed Gas Sampling Cannula with O2 delivery
Westmed, Inc.
CCK
Mar 10, 2016K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
Salter Labs
CCK
Jul 17, 2015K150272Capnostream 35 Portable Respiratory Monitor
Oridion Medical 1987 , Ltd., IL
CCK
Jul 17, 2015K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
GE Healthcare Finland Oy, FI
CCK
Feb 13, 2015K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
Dispo-Med (Malaysia) Sdn Bhd, MY
CCK
Feb 12, 2015K143469SOFTECH Plus ETCO2 Cannula
Teleflexmedical, Inc.
CCK
Feb 5, 2015K143150CO2 monitoring line with and without in-line filter
Besmed Health Business Corp, TW
CCK
Nov 24, 2014K142467IntelAir Nasal Airway Support System
Abeon Medical Corporation
CCK

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