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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: FFX FDA class 2

    System, Gastrointestinal Motility (Electrical)

    Gastroenterology, Urology

    View full classification →

    The Electrical Gastrointestinal Motility System is a diagnostic device that uses electrical sensors and recording equipment to measure and characterize the motility and motor function of the gastrointestinal tract. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FFX, regulated under 21 CFR 876.1725, within the Gastroenterology, Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Solar Compact (G4-1)
    EndoflipTM 300 System
    EndoflipTM 300
    Transit-Pellets
    IntraMarX 3D Radiopaque Marker
    IntraMarX Radiopaque Markers
    Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
    Transit-Pellets
    EndoFLIP System
    SITZMARKS
    EndoFLIP® System with FLIP Topography module
    Rapid Barostat Bag (RBB) Pump and Catheter
    Lehman Manometry Catheter
    EndoFLIP
    ManoScan System
    ENDOFLIP CATHETER
    PRESSURIZED INFUSION PUMP
    BAROSTAT SOFTWARE OPTION
    SOLAR GI
    SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
    ENDO FLIP
    PHTIP DISPOSABLE ISFET CATHETER
    ENDOFLIP
    MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
    ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
    MODIFICATION TO SOLAR GI
    UNITIP HIGH RESOLUTION CATHETER
    OHMEGA
    SOLAR GI
    SOLAR GI SYSTEM
    MOTILITY VISUALIZATION SYSTEM
    BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
    INSIGHT, MODEL S980000
    MARK II/MARK III MANOMETRIC PERFUSION PUMP
    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
    UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
    SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
    REDTECH GIPC 2000
    POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
    POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
    ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
    DISTENDER SERIES II BAROSTAT
    GASTRIC AND RECTAL CATHETERS
    INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
    DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
    INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
    MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
    MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
    ANORECTAL MANOMETRY ANALYSIS MODULE

    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.

    Popular Product Codes

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