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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: GIM FDA class 2

    Tubes, Vacuum Sample, With Anticoagulant

    Clinical Chemistry

    View full classification →

    Tubes, Vacuum Sample, with Anticoagulant (product code GIM) are evacuated blood collection tubes containing an anticoagulant additive, used to collect and preserve blood specimens for clinical chemistry and other laboratory analyses by preventing clotting during specimen transport and processing. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 862.1675 in the Clinical Chemistry specialty (CH), this device carries no flags for implantation, life support, GMP exemption, or third-party review.

    510(k) Clearances

    39 matches
    K Number
    Device Name
    BD Vacutainer® Citrate Blood Collection Tubes
    BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
    BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
    TransFix/EDTA Vacuum Blood Collection Tubes
    CYTO-CHEX BCT
    DS30 HCY BLOOD COLLECTION TUBES
    VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
    GREINER VACUETTE BLOOD COLLECTION TUBE
    LOK-ON NEEDLE DISPOSAL SYSTEM
    VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
    CORVAC PLASTIC BLOOD COLLECTION TUBE
    MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
    BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
    VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
    MULTIDRAW SYSTEM
    ANGEL WING SETS -- MODIFIED
    DIRECTDRAW SUPERSERUM
    VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
    ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.
    CORVAC BLOOD COLLECTION TUBE
    VACUTAINER KIT
    1400 SERIES EVIDENCE COLLECTION KIT
    QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
    ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
    VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
    SYRINGE FOR BLOOD SAMPLING
    PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
    PRE-DENT
    J-VAC VACUUM TUBE
    FILTER SAMPLER BLOOD SERUM FILTER
    LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
    LIQUAEMIB SODIUM PRESERVATIVE, ETC.
    BLOOD COLLECTION TUBE, GREEN
    BLOOD COLLECTION TUBE, GRAY
    BLOOD COLLECTION TUBE, BLUE
    BLOOD COLLECTION TUBE, RED
    BLOOD COLLECTION TUBE, LAVENDER
    VACUUM TUBES, STERILE (J-VAC)
    VACUUM TUBES, PEDIATRIC SIZES (J-VAC)

    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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