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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: CEM FDA class 2

    Electrode, Ion Specific, Potassium

    Clinical Chemistry

    View full classification →

    The Ion-Specific Electrode Potassium Test is a clinical chemistry device that measures potassium ion concentration in blood or other biological fluids using a potassium-selective electrode, providing a rapid and accurate means of assessing electrolyte status, used in the management of cardiac arrhythmias, renal disease, and fluid-electrolyte disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEM, regulated under 21 CFR 862.1600, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
    ABL90 FLEX PLUS System
    EasyStat 300
    ISE Electrodes
    SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
    FLEXLAB 3.6, ACCELERATOR A3600
    SMARTLYTE ELECTROLYTE ANALYZER
    GEM PREMIER 4000
    BIOLIS 12I
    AU5800(R) CHEMISTRY ANALYZER
    POLY-CHEM 90 ISE MODULE
    EASTLYTE NA/K/CA/PH
    ABL90 FLEX SERIES
    BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
    ACCELERATOR APS
    VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
    VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
    OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
    RX IMOLA
    COBAS 6000 SERIES SYSTEM
    UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
    BIO-CHEM ANALYZER, MODEL 100
    STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
    ROCHE DIAGNOSTICS OMNI S ANALYZER
    OMNI C ANALYZER
    DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
    ALCYON 300I (WITH ISE MODULE) ANALYZER
    AVL OPTI CRITICAL CARE ANALYZER
    DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
    EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
    EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+)
    DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
    NOVA NA/K/CL/LI MODULE
    MILES POTASSIUM METHOD
    STAT K SYSTEM
    NOVA 5 NA/K/C1 ALALYZER
    NOVA 11 NA/K/LI ANALYZER
    ISE/K+
    MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
    IONOMETER EH
    IONOMETER EH-HK AND ACCESSORIES
    LYTENING 2Z LYTENING SYSTEM 31
    SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
    AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
    TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
    POTASSIUM AND SODIUM ELECTROLYTE ANALYZER
    MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
    VISION LYTE (TM) POTASSIUM
    AVL MODEL 986 ELECTROLYTE ANALYZER

    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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