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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: JSH FDA class 1

    Culture Media, Non-Selective And Differential

    Microbiology

    View full classification →

    The Culture Media, Non-Selective and Differential is a microbiology diagnostic medium that supports the growth of a wide variety of microorganisms but contains indicators or reagents that produce visible differences in colony morphology or color based on the organisms' metabolic properties, enabling differentiation of colony types without inhibiting growth. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSH and is regulated under 21 CFR 866.2320, within the Microbiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PHENOL RED BROTH BASE
    FLO AGAR
    UREA BROTH
    RUSSELL DOUBLE SUGAR AGAR
    DNASE TEST AGAR
    UREA AGAR BASE
    MOELLERS DECARBOXYLASE, BASE
    OF MEDIUM BASE
    ACTINOMYCETE DIFFERENTIAL MEDIA
    MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA
    SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084
    LYSINE IRON AGAR (LIA) PRODUCT #T3046
    MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053
    IAFP MAC CONKEY AGAR
    MUCATE AGAR, SLANTS AND MUCATE BROTH
    SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
    ARYLSULFATASE BROTH
    HEMOPHILUS ID QUAD PLATE
    BIGGY AGAR
    CLED AGAR
    CLED AGAR WITH ANDRADES INDICATOR
    THERMOSTABLE NUCLEASE TEST AGAR
    THERMONUCLEASE AGAR W/TOLUIDINE BLUE
    TRYCOPHYTON AGARS
    XANTHINE/TYROSINE/CASEIN AGAR
    MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM
    BIRD SEED AGAR
    STARCH AGAR W/BROM CRESOL PURPLE
    TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR
    BIOTIS HAEMOPHILUS IDENTIFICATION QUAD
    BIOTIS DECARBOXYLASE MEDIA, BASE
    PSEUDOMONAS AGAR P (MEDIUM A)
    APL TRIPLE SUGAR IRON AGAR
    APL MOTILITY INDOLE ORNITHINE AGAR
    APL SIM MEDIUM
    APL DNASE TEST AGAR
    APL BILE ESCULIN/AZIDE AGAR
    APL CHLAMYDOSPORE AGAR
    APL GN BROTH
    APL FLUID THIOGLYCOLLATE MEDIUM
    DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR
    CLED AGAR
    DRI-FORM PSEUDOMONAS AGAR F
    SIM MEDIUM
    SIMMONS CITRATE AGAR
    TRIPLE SUGAR IRON AGAR
    BIGGY AGAR NICKERSONS MEDIUM
    UREA AGAR
    OXIDATIVE FORMENTIVE MEDIUM
    PURPLE BROTH

    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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