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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: FEB FDA class 2

    Accessories, Cleaning, For Endoscope

    Gastroenterology, Urology

    View full classification →

    The Cleaning Accessories for Endoscope (product code FEB) are tools and supplies used in the manual cleaning and reprocessing of endoscopes to remove biological material and prepare the instrument for disinfection or sterilization. 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. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CORIS System
    System 83 Revolve Endoscope Washer/Disinfector
    enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
    enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
    SCOPE BUDDY PLUS Endoscope Flushing Aid
    Endoscope Reprocessor OER-Elite
    System 83 Plus Washer/Disinfector
    ENDOSCOPE REPROCESSOR OER-Elite
    AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
    Acu-sInQ Complete Endoscope Cleaning Aid System
    Advantage Plus Pass-Thru
    Scope-Assist Flushing Sink
    Scope Buddy Plus Endoscope Flushing Aid
    EVOTECH ECR
    EVOTECH ECR
    SYSTEM 83 PLUS
    ENDOSCOPE REPROCESSOR OER-MINI
    LIC INSTRUMENT PROCESSING SYSTEM
    ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
    MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
    ENDOSCOPE REPROCESSOR OER-PRO
    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT
    EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
    MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
    SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
    EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
    MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
    EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
    RIWO SYSTEM TRAYS
    PSK ENDOSCOPE CLEANING SYSTEM
    VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
    BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
    VIRAPUMP II (MODELS AND MODEL M)
    MILL-ROSE RIGID SCOPE CLEANING BRUSHES
    EW-10 AND EW-20
    CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT
    AUTO SUTURE* ANTI-FOG DEVICE**
    BLUE PLANET LENS FOG REDUCTION & CLEANING KIT
    EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT
    FLUID PUMP, CP #3
    DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
    ENDOWASH
    HOBBS MEDICAL CLEANING BRUSH
    CANDELA MINIBRUSH
    FLEXIBLE URETERONEPHROSOCOPE
    OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
    COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)
    CLEANING BRUSH
    ONE DIRECTIONAL CLEANING BRUSH

    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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