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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: GKL FDA class 2

    Counter, Cell, Automated (Particle Counter)

    Hematology

    View full classification →

    Counter, Cell, Automated (Particle Counter) (product code GKL) is an automated hematology instrument that uses electrical impedance or optical detection to enumerate and size blood cells and other particles in suspension, forming the core technology of modern complete blood count (CBC) analyzers. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5200 in the Hematology specialty (HE), it is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Glocyte Automated Cell Counter System
    IQ 200 URINE ANALIZER BODY FLUIDS MODULE
    HEMOCUE WBC SYSTEM
    MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
    IQ 200 URINE ANALYZER BODY FLUIDS MODULE
    SYSMEX POCH-100I
    ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
    SYSMEX R-500
    COULTER Z2 ANALYZER
    SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
    SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
    ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
    SYSMEX SE/RAM-1
    COULTER GEN-S SYSTEM
    RETICULOCYTE METHOD
    YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
    COULTER Z 1
    THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
    TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
    QBC HEMACAN HEMATOLOGY SYSTEM
    IVOS ANALYZER
    YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
    SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
    SYSMEX F-810
    SYSMEX F-310
    SYSMEX F-610
    GENESIS I AUTOMATED CELL COUNTER
    SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
    COULTER FLOW RETICULOCYTE REAGENT
    NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
    FACSMATE SAMPLE HANDLING DEVICE
    KVM BLOOD CELL COUNTER
    RETICCOUNT SOFTWARE
    CELLECT LABTRAK SOFTWARE
    CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
    HAMILTON-THORN MOTILITY ANALYZER HTM-2000
    DIGICELL 300 SYSTEM
    DIGICELL 500
    FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
    NAPSAC(TM)
    TECHNICON H*1 JR.(TM) SYSTEM
    SYSTEM 9000 AUTOMATED CELL COUNTER
    ATAC 4300 HEMATOLOGY CELL COUNTER
    IL CELLECT 8
    COULTER COUNTER MODEL T-540
    CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
    IL CELLECT 7
    COULTER COUNTER MODEL T-890
    COULTER COUNTER MODEL S PLUS JUNIOR
    PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS

    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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