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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: JKA FDA class 2

    Tubes, Vials, Systems, Serum Separators, Blood Collection

    Clinical Chemistry

    View full classification →

    This device includes tubes, vials, systems, and serum separators used in clinical laboratories for blood collection and specimen preparation, enabling proper separation of serum or plasma from cellular components for downstream biochemical testing. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence. The product code is JKA, regulated under 21 CFR 862.1675, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Female Culture Device; Male Culture Device; Transfer Device; Access Device
    BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
    BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder
    BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
    BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
    Steripath® Flow™ Blood Collection System
    BD Vacutainer® Eclipse™ Blood Collection Needle
    Blood collection tube holders
    Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
    Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
    BD Vacutainer® Multiple Sample Luer Adapter
    PIVO™ Pro Needle-free Blood Collection Device
    BD Vacutainer® One Use Holder
    VACUETTE® QUICKSHIELD Complete (Plus)
    Safety Sliding Blood Collection Set
    BD Vacutainer® K2 EDTA Blood Collection Tubes
    LifeOutcomes C-Quest™ Blood Culture Sampling Device
    BD Vacutainer® Fluoride Blood Collection Tubes
    Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
    BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
    Monarch Blood Collection Set
    BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
    Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
    UltraFlo-R Push Button Blood Collection Set
    PIVO™ Pro Needle-free Blood Collection Device
    BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
    Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
    Unistik® ShieldLock, Unistik VacuFlip
    K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
    Kurin Blood Culture Collection Set with Kurin Lock Technology
    Blood Collection Needle (with/without Needle Holder)
    BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
    BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device
    Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
    Steripath Micro Blood Collection System
    Eclipse Blood Collection Set
    Safety Blood Collection Needle (Without Needle Holder)
    Velano Vascular Blood Collection Adapter
    SOL-GUARD Safety Pull Button Collection Set
    K-SHIELD Zen
    Safety Blood Collection Needles with/without Needle Holder
    20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
    BD Vacutainer UltraTouch Push Button Blood Collection Set
    Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
    CHIRAVAC Blood Collection Needles
    EasyPoint Blood Collection Plus
    Safety Blood Collection Sets for Single Use
    BD Preset Syringe & BD A-Line Syringe
    Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
    Bevel Up Holder

    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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