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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: KPL FDA class 2

    Colonic Irrigation System

    Gastroenterology, Urology

    View full classification →

    This device is a colonic irrigation system used to flush the large intestine with water or other solutions, employed therapeutically to cleanse the colon prior to procedures or in the management of certain bowel conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPL, regulated under 21 CFR 876.5220 within the Gastroenterology and Urology specialty. No special flags apply.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    Bio Fluff System
    Colonic Plus Regular, Small, and Straight Shape Hydrokit
    Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
    AQUA CLEANSE
    HC-1 AND HC-1 CLASSIC
    THE WATER LILY
    COLONIC & ENEMA NOZZLE
    COLONIC AND ENEMA NOZZLE
    CONMED IRRIGATION NOZZLE
    PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
    ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
    ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
    GENTLE COLONICS IRRIGATION SYSTEM
    AQUANET, MODEL EC 2000
    CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
    GC IRRIGATOR
    TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
    JIMMY JOHN III RECTAL NOZZLE
    JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
    LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
    CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
    LOWER BOWEL EVACUATION SYSTEM
    SYSTEMS FLOW 2000
    ENEMA KIT
    HYDRO-SAN COLONIC IRRIGATION SYSTEM
    CUFF SPECULUM
    BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
    JIMMY JOHN III
    MODIFIED RECTAL NOZZLE
    DOTOLO COLON HYDROTHERAPY INSTRUMENT
    JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
    MODIFIED JIMMY JOHN III
    HYDRO-CLENZ UNIT
    JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
    JIMMY JOHN III
    COLON IRRIGATION UNIT
    SARNS INFANT ARTERIAL BUBBLE SENSOR
    HESSLER COLON THERAPY DEVICE
    NON-RETENTION ENEMA SYSTEM
    INTERNAL ECOLOGY MACHINE

    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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