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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: FDX FDA class 2

    Endoscopic Cytology Brush

    Gastroenterology, Urology

    View full classification →

    The Endoscopic Cytology Brush (product code FDX) is a brush-tipped device passed through an endoscope to collect cells from the mucosal surface of the gastrointestinal or genitourinary tract for cytological evaluation and cancer screening. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    43 matches
    K Number
    Device Name
    Single Use Cytology Brush
    Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
    Deflectable Brush Biopsy Set
    Brush Biopsy Set ; Deflectable Brush Biopsy Set
    Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
    Cytology Brush
    Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
    Bronchi and Gastrointestinal Cytology Brush
    Infinity ERCP Sampling Device
    US ENDOSCOPY CYTOLOGY BRUSH
    COOK IRELAND ECHOBRUSH
    WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
    HORIZONS CYTOLOGY BRUSH
    CELL RECOVERY SYSTEM
    CELL RECOVERY SYSTEM
    CYTOLOGY BRUSH
    MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
    URETHRA-BRUSH
    COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
    AMCATH DISPOSABLE CYTOLOGY BRUSH
    CYTOLOGY BRUSH
    CYTOLOGY BRUSH
    CYTOLOGY BRUSH
    COX DISPOSABLE CYTOLOGY BRUSHES
    CYTOLOGY BRUSH
    COX DISPOSABLE CYTOLOGY BRUSHES
    LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
    BC BRUSHES
    GASTROINTESTINAL CYTOLOGY BRUSH
    BRONCHIAL CYTOLOGY BRUSH
    WILSON-COOK CYTOLOGY BRUSHES
    PORGES CYTOLOGY BRUSHES
    WILTEK CYTOLOGY BRUSH
    HOBBS MEDICAL MICROBIOLOGY BRUSH
    BERGER PROSTATE CULTURE CYTOLOGY BRUSH
    GASTROINTESTINAL CYTOLOGY BRUSH
    ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
    BARD URETEROSCOPIC CYTOLOGY BRUSH
    GASTROINTESTINAL SHEATH BRUSH
    MUTO BRUSH
    M.R. ASSOC. CYTOLOGY BRUSHES
    ENDOSCOPIC CYTOLOGY BRUSHES
    UROLOGICAL BIOPSY BRUSH SET

    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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