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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: ILO FDA class 2

    Pack, Hot Or Cold, Water Circulating

    Physical Medicine

    View full classification →

    A Water Circulating Hot or Cold Pack is a Physical Medicine thermal therapy device that uses temperature-controlled circulating water through a pad or wrap applied to the body, providing sustained therapeutic heating or cooling for pain relief, inflammation management, or rehabilitation. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILO, regulated under 21 CFR 890.5720, within the Physical Medicine medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Armory Motion
    COOLSKIN
    T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
    JUNIPER CLN1 DERMAL COOLING DEVICE
    MODIFICATION TO POLAR CARE 500
    IVC SYSTEM
    INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
    HTP-1500 LOCALIZED HEAT THERAPY PUMP
    ARTOCOOL-S WATER CIRCULATING COLD PACK
    ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
    BLEDSOE COLD CONTROL
    MODEL 1100 COLD THERAPY DEVICE
    STERILE SOFT-TEMP
    INCARE HOT/ICE SYSTEM SHOULDER BLANKET
    INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
    POLAR CARE 300
    INCARE HOT/ICE LITE MACHINE
    THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
    BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
    EBI THERMAL THERAPY SYSTEM
    POLAR CARE (MODEL 500/50000)
    CRYTRON SYSTEM
    SPORTS CONTRAST THERAPY SYSTEM ST 7000
    MODEL 1100 COLD THERAPY DEVICE
    MEDICOOL (MODIFICATON)
    THERMOTEK H-300
    EBICE
    THERMOCOOL SYSTEM
    T-350 THERAPEUTIC COOLING MACHINE
    T-300 COOLER
    CONTRAST 7000 THERAPY SYSTEM
    BABYTHERM 8000 WB
    HPRH HOSPITAL PATIENT RADIANT HEATER
    DELTA THERM COLD THERAPY SYSTEM
    EBICE
    TOTALLY COOL(TM) TC-1
    TOTALLY COOL(TM) TC-2
    COOL/HEAT THERAPY APPLICATOR
    INCARE HOT/ICE COLD THERAPY COOLER
    DR KOOL
    THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
    ORTHO TECH CRYOLOGIC SYSTEM
    ISOCOMFORTER
    TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
    HYDROT
    COOL-AID
    HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
    SUR FLO THERMAL THERAPY PADS
    LSI6000 THERMAL THERAPY SYSTEM
    AUTOCHILL ACCESSORY KIT

    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.

    Popular Product Codes

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