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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: CCK FDA class 2

    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    Anesthesiology

    View full classification →

    The Gaseous-Phase Carbon-Dioxide Analyzer is an anesthesiology device that measures the concentration of carbon dioxide in the gas phase of a breathing circuit, used to monitor end-tidal CO2 levels and assess adequacy of ventilation during anesthesia and intensive care. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCK, regulated under 21 CFR 868.1400, within the Anesthesiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
    AIM (N/A)
    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
    Oxy2Pro
    Endure ETCO2/02 Nasal Cannula
    CO2 Mainstream Sensor
    XChange Device, XChange System
    Endoscopy Oxygen Mask
    Microstream CO2 NanoPod
    CARESCAPE CO2 Microstream parameter
    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
    Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
    EMMA Capnograph
    Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
    CO2 Sidestream Module
    CO2 Mainstream Module
    Capnostream 35 Portable Respiratory Monitor
    Altera gas Sampling Lines
    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
    MaxCap Ped and MaxCap Neo
    CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
    Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
    Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
    CO2 Sampling Line
    MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
    Capnograph and Oximeter
    SuperNO2VA Et Device
    ETCO2 Sensor
    Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
    Panoramic Oxygen Mask (POM)
    OmniCap
    IntelliVue Capnography Extension, IntelliVue Microstream Extension
    Nihon Kohden CO2 Monitor
    CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
    OC-FLEX Flexible IntraOral Cannula
    TG-970P CO2 Sensor Kit
    Westmed Gas Sampling Cannula with O2 delivery
    Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
    CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
    Capnostream 35 Portable Respiratory Monitor
    CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
    SOFTECH Plus ETCO2 Cannula
    CO2 monitoring line with and without in-line filter
    IntelAir Nasal Airway Support System
    CAPNOSTREAM20P WITH HIFI C02 MONITORING
    SOFTECH PLUS ETC02 CANNULA
    CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
    DUALGUARD
    FLOCAP

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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