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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: JQC FDA class 1

    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

    Clinical Chemistry

    View full classification →

    The Centrifuges (Micro, Ultra, Refrigerated) for Clinical Use encompasses a range of laboratory centrifuge instruments used to separate blood, urine, or other biological specimens by centrifugal force for clinical laboratory analysis, including microcentrifuges, ultracentrifuges, and refrigerated models used for specialized separation protocols. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. It carries product code JQC and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.

    510(k) Clearances

    38 matches
    K Number
    Device Name
    PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
    SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
    AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
    MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
    GENESISCS COMPONENT CONCENTRATING SYSTEM
    SMARTPREP2 CENTRIFUGE SYSTEM
    COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
    SECQUIRE CELL SEPARATOR
    GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
    AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
    MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
    3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
    SMARTPREP CENTRIFUGE SYSTEM
    SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
    STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
    GENERAL PURPOSE CENTRIFUGE
    MODEL K110SX CENTRIFUGE
    DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)
    QWIKSPIN (TM)
    ROTOR SYSTEMS A/S-400 & LA/S-400
    ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.
    EBA 3 S CENTRIFUGE
    UNIVERSAL 2 S CENTRIFUGE
    CENTRIFUGES
    LKB 2161 MIDISPIN R CENTRIFUGE
    LKB 2160 MIDISPIN CENTRIFUGE
    LKB 2164 MACRO-SPIN R CENTRIFUGE
    PLATELET CENTRIFUGE
    BASIC CENTRIFUGE
    IEC CENTRA 4 CENTRIFUGE
    CENTIDISC
    PALL ULTIPOR VACUUM LINE BACTERIA FITLER
    SORVALL RT6000 REFRIGERATED TABLETOP
    CONICAL TIPPED CENTRIFUGE TUBE 15M
    REFRIG. CENTRIFUGE (DRUCKER MODEL)
    IEC CENTRA-7 CENTRIFUGE MODEL 2362
    SPINETTE CENTRIFUGE
    ROTATOR, FIXED SPEED

    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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