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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: FFT FDA class 1

    Electrode, Ph, Stomach

    Gastroenterology, Urology

    View full classification →

    The Stomach pH Electrode is a diagnostic device inserted into the stomach to measure intragastric acidity, used in the evaluation of gastroesophageal reflux disease and other acid-related conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification requirement. The product code is FFT, regulated under 21 CFR 876.1400, within the Gastroenterology, Urology medical specialty.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    BRAVO PH MONITORING SYSTEM AND ACCESSORIES
    SANDHILL SCIENTIFIC PEDIATEC PH PROBE
    BRAVO PH MONITORING SYSTEM
    PH ANALYSIS MODULE
    LOT 440
    TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR
    FLEXILOG 2000
    TRIP CIC CATHETER
    CYBERRX MODEL 7200
    ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.
    SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
    MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
    PH METER, MODIFICATION
    SUPERLOGGER
    DIGITRAPPER MARK III
    TRIP(TM) NASOGASTRIC SUMP CATHETER
    ZINETICS INTERNAL REFERENCE PROBE
    GASTROGRAPH
    MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT
    FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
    GIPHY MONITOR
    NASOGASTRIC PH SUCTION CATHETER, ST-5001
    TONOMITOR (TM) + SUMP
    PROXIMA 1 PH MONITOR
    DIAMOND MEDICAL, INC. MODEL DM 800
    DIAMOND MEDICAL, INC. MODEL DM 600
    MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT
    PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.
    GENERAL PURPOSE COMBINATION PH ELECTRODE
    PH MONITORING SYSTEM
    SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE
    TONOMITOR(TM)
    DIAMOND MEDICAL, INC., MODEL DM 700
    ZINETICS GASTROMETER (TM)
    SYNECTICS MOTILITY SYSTEM
    MODEL 1010 AMBULATORY PH MONITORING SYSTEM
    AMBI-24 PH/PRESSURE MONITOR
    FOUR CHANNEL PH PROBE
    SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO
    MODEL SA3 ESOPHAGEAL PH ELECTRODE
    SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE
    SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
    ESOPHOGEAL PH CATHETER
    SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT
    PROXIMA 1 PH MONITOR
    SANDMILL RMS
    MODEL 700 GASTROREFLUX MONITOR/AMALYZER
    PATIENT ISOLATOR #S-10/D-10
    ESOPHAGEAL MOTILITY PROBE

    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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