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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: KIT FDA class 1

    Media And Components, Synthetic Cell And Tissue Culture

    Hematology

    View full classification →

    Synthetic Cell and Tissue Culture Media and Components are chemically defined or partially defined liquid or dry formulations used to support the growth, maintenance, and passage of mammalian cells in vitro, providing essential nutrients, amino acids, vitamins, and buffering agents required for cell culture in laboratory diagnostic and research applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIT, regulated under 21 CFR 864.2220, within the Hematology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AMNIO-GROW TM
    ENDOTHELIAL GROWTH MEDIUM (EGM)
    MELANOCYTE GROWTH MEDIUM (MGM)
    ABC, ABC-1X, ABC(TM)
    ALPHACALF SERUM
    DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785
    HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891
    RPMI-1640 HYBRI-MAX, PROD. NO. R5382
    ALLOPREP SYSTEM
    FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT
    MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)
    CHANG MEDIUM (ADDITIONAL INDICATIONS)
    HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013
    EX-CELL 300TM, CATALOG # 210-3579
    MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150
    EX-CELL 300TM, CATALOG NO. 200-3601
    EX-CELL 300TM, CATALOG NO. 200-3600
    EX-CELL 301, CATALOG NO. 210-3577
    EX-CELL 301, CATALOG NO. 200-3651
    RPMI-1640 MEDIUM, CATALOG NO. 210-3525
    MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051
    EX-CELL 300TM, CATALOG NO. 210-3575
    SFRE 199-1 MEDIUM, CATALOG NO. 200-2191
    L-15 MEDIUM, CATALOG NO. 210-4004
    MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511
    MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048
    FISCHER'S MEDIUM CATALOG NO. 210-4007
    ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505
    HORSE SERUM, ABATTOIR, NO. 110-1112
    FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122
    MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531)
    MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517
    FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123
    ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105
    FETAL BOVINE SERUM, DEFINED NO. 110-1121
    MEDIUM 199, 10X, CATALOG NO. 210-3557
    HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012
    MCCOY'S 5A MEDIUM 10X NO. 210-3532
    MEDIUM 199, CATALOG NO. 200-2031
    L-15 MEDIUM, CATALOG NO. 200-2021
    MEDIUM 199, 10X, CATALOG NO. 210-3555
    CALF SERUM, CATALOG NO. 110-1125
    NEWBORN CALF SERUM, CATALOG NO. 110-1130
    SFRE 199-2 MEDIUM, CATALOG NO. 200-2192
    MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046
    MEDIUM 199, 10X CATALOG NO. 210-3556
    CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177
    RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120
    MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110
    MINIMUM ESSENTIAL MED (MEM,THERMO-POW(R)#200-2090

    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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