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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: KIR FDA class 1

    Cells, Animal And Human, Cultured

    Hematology

    View full classification →

    Cultured Animal and Human Cells are living cell preparations derived from animal or human sources, maintained in culture for use as laboratory reagents in biological assays, virus propagation, cytotoxicity testing, and other in vitro diagnostic and research laboratory 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 KIR, regulated under 21 CFR 864.2280, within the Hematology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FRESH CELLS HFF
    FRESH CELLS VERO
    FRESH CELLS WI-38
    FRESH CELLS NCI H292
    FRESH CELLS MV1LU
    FRESH CELLS LLC-MK2
    RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
    FRESHCELLS
    MINK LUNG CELL CULTURE
    FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
    FRESHFROZENCELLS
    FRESHCELLS, HEP-2
    FRESHFROZEN CELLS, HEP-2
    MCCOY CELL CULTURES
    H292 CELL CULTURE
    NCI-H292 CELL CULTURE
    LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
    A549 CELL CULTURE
    MRC-5 CELL CULTURE VIAL
    H292
    PRIMARY RABBIT KIDNEY CELL CULTURE
    VERO CELL CULTURE
    MDCK CELL CULTURE
    BGM CELL CULTURE
    RD CULTURE CELL
    WI38 CELL CULTURE
    PRIMARY MONKEY KIDNEY CELL CULTURE
    HUMAN NEWBORN FORESKIN CELL CULTURE
    FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
    FRESH FROZEN CELLS
    HEP-2 CULTURE CELL
    MRC-5 CULTURE CELL
    A549 CULTURE CELL
    LLCMK2 CULTURE CELLS
    MCCOY CULTURE CELL
    RHESUS MONKEY KIDNEY CELLS
    TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
    RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
    RABBIT KIDNEY CELLS - R.K.C.
    HELA-229/HELA CELLS
    PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
    BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.
    HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
    LUNG CACINOMA, HUMAN CELLS
    KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
    RHABDOMYOSARCOMA CELLS
    HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.
    CYNOMOLOGUS MONKEY KIDNEY CELLS
    MCCOY CULTURE CELLS-MCCOY
    HELA HELA EPITHELOID CARCINOMA

    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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