BEUDAMED
    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: IMD FDA class 1

    Pack, Hot Or Cold, Disposable

    Physical Medicine

    View full classification →

    A Disposable Hot or Cold Pack is a single-use Physical Medicine thermal therapy product that provides either heat (through an exothermic chemical reaction) or cold (through an endothermic chemical reaction) for temporary localized pain relief, reduction of inflammation, or muscle relaxation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IMD, regulated under 21 CFR 890.5710, within the Physical Medicine medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    InfaTherm Disposable Infant Warming Mattress
    Infant Transport Mattress Warmer with Disc
    NEO NEST
    EYEFEEL OPHTHALMIC WARMER
    BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
    EYEFEEL OPHTHALMIC WARMER
    ALLEGIANCE PORTA-WARM MATTRESS
    DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
    CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
    ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
    KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
    RECOVER ADULT VEIN WARMER
    INSTANT HOT PACKS
    INSTANT COLD PACK
    TEMPRA COLD PACK, REORDER NO. TC150
    OMNI COLD GEL PACKS
    IMNI HOT PACKS
    ANDELA DYNAMIC COOLING DEVICE
    CERTI COOL INSTANT COLD COMPRESS
    OMNI COLD GEL PACKS
    RESTORE, THERMACELLS (HOT PACK I)
    COLDGEL
    INSTANT COLDGEL
    INFANT HEEL WARMER
    TEMPRA HEAT PACK
    POLY-MEDICS HEAT PACK
    OMNI WARM GEL PACKS
    INSTANT HOT OR COLD DISPOSABLE PACK
    CERTI HEAT INSTANT HEAT COMPRESS
    TRANSWARMER
    KACEY DISPOSABLE INFANT HEEL WARMER
    PERI-K PAD COLD PACK
    ANAGO WARM PACK
    ANAGO FEM-COOL/FEM-COOL PETITE
    ANAGO DISPOSABLE INSTANT COLD PACK
    CURAD KID SIZE INSTANT COLD PACK
    INSTANT WARM GEL PACK
    SHUR-LOCK ICE WRAP SYSTEM
    LIBERTY HOT PACK AND LIBERTY KOLD PACK
    INSTANT ICE PACK
    3M HEAT COMFORT PORTABLE SELF-HEATING PAD
    MEDI-PACK
    STAT-PAD
    THERMO-PACK
    CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS
    CP&S DISPOSABLE INSTANT COLD COMPRESS
    HARE COLD PACK
    GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER
    HYPERTHERM TECHNOLOGIES' HEAT COMPRESS
    INSTANT COLD COMPRESS, CHEMICAL TYPE

    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

    Commonly searched
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