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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: JQP FDA class 1

    Calculator/Data Processing Module, For Clinical Use

    Clinical Chemistry

    View full classification →

    The Calculator/Data Processing Module, For Clinical Use is a clinical laboratory device or software module used to perform calculations and process data generated during clinical chemistry and other diagnostic testing, including computation of results, reference ranges, and quality control statistics to support accurate reporting of patient test results. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQP and is regulated under 21 CFR 862.2100, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BIONIME DIABETES MANAGEMENT SYSTEM VI.0
    FASTTAKE ADAPTER, MODEL # P/N 020-072-01
    THE ROBOLITE
    PRENVAL I
    MR7000 WITH TIME MANAGER SOFTWARE (TMS)
    EXPRESSO CARTRIDGE
    MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
    CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
    COBAS MFC
    RIA-QUICK
    V-MARC 88A COMPUTER
    KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
    710 PLUS
    GLUCOFACTS DATA MANAGEMENT SYSTEM
    GLUCOFACTS DATA PRINTER
    CLINIFACTS 200 DATA MANAGEMENT SYSTEM
    DIRECT READOUT MODULE ACCESSORY
    SIMULATOR
    BIOVATION MAX DATA MANAGEMENT SYSTEM
    ATAC 2000 CHEMISTRY ANALYZER
    SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
    CLINIFACTS 10 DATA MANAGEMENT SYSTEM
    ISO-DATA IMMUNOASSAY NETWORK SYSTEM
    CHEMISTRY CONSOLE
    LYRIS MODULAR INFO SYSTEM
    GELSCAN SOFTWARE 2190
    CATS-CLINICAL LAB COMPUTER SOFTWARE-
    HYBRITECH DATA STATION
    LABORATORY DATA MGMT SYSTEM SDMS
    ACLAIM-QAP IBM PERSONAL COMPUTER EDT
    DUPONT LINEARIZATION MODULE
    BLOOD GAS QUALITY CONTROL SOFT-86000F
    RIA SOFTWARE
    CORNING 102 PRINTER
    API MDS*
    NML 6000 CT
    BLOOD GAS EXPER. SYSTEM 8700
    QAP MICROCOMPUTER SYSTEM
    EMIT CLINICAL PROCESSOR #CP-5000
    RIA SSIST TI-59 MAGNETIC CARD PROGRAMS
    SYVA LAB PROCESSOR 6000
    CORNING 101 PRINTER
    AMERIFLOUR FLUOROMETER
    EMIT TIMER UNIT #100
    715 DELTA TERMINAL
    COMPUTERIZED INTERPRETATION OF ARTERIAL
    IL 8060 DATA MANAGEMENT SYSTEM
    BIOVATION URINALYSIS REPORTER
    BCD-HPP41C INTERFACE
    DPM CALCULATOR

    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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