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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: JIY FDA class 1

    Photometric Method, Iron (Non-Heme)

    Clinical Chemistry

    View full classification →

    This device is a photometric reagent system used in clinical chemistry laboratories to measure non-heme iron concentrations in serum or other biological specimens, used in the diagnosis and monitoring of iron deficiency anemia, hemochromatosis, and related disorders. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket notification required. The product code is JIY, regulated under 21 CFR 862.1410, and falls within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
    DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
    SENTINEL IRON LIQUID
    VITALAB IRON REAGENT
    ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
    IRON-PC-SL ASSAY MODEL # 151-10, 151-26
    WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
    IRON
    SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
    IL TEST IRON
    IRON REAGENT
    TOTAL IRON (NITRO-PAPS) REAGENT SET
    IRON/TIBC REAGENT
    ACE IRON REAGENT
    IRON QVET
    DMA IRON PROCEDURE
    IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM
    IRON TEST
    IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
    OLYMPUS IRON REAGENT
    OLYMPUS IRON REAGENT
    THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
    KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
    TOTAL IRON FOR MANUAL/AUTOMATED
    COULTER SERUM IRON/UIBC REAGENT
    IRON/TOTAL IRON BINDING CAPACITY
    IRON LIQUID STABLE REAGENT
    SYSTEMATE(TM) IRON ITEM NUMBER: 65417
    IRON SYSTEM PACK REAGENTS
    EASY-TEST IRON (IRON) ITEM NO. 16686
    KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
    BIOTROL IRON REAGENT
    IRON REAGENTS ITEM NUMBER: SR1017
    PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
    TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS
    IRON TEST
    PARAMAX IRON REAGENT
    IRON PROCEDURE
    STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
    IRON PROCEDURE
    WAKO(TM) FE C
    LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT
    FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
    IRON(IRN) TESTPACK, ITEM NO. 67659/95
    RAICHEM (TM)SERUM IRON AND TIBC REAGENTS
    FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
    FERROFAST
    IRON PROCEDURE
    IRON PROCEDURE

    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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