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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: HIR FDA class 2

    Perineometer

    Obstetrics/Gynecology

    View full classification →

    The Perineometer is a diagnostic instrument used to measure the strength and endurance of pelvic floor muscles, particularly the vaginal and perineal musculature, often employed in assessment and biofeedback therapy for pelvic floor disorders. It is classified as FDA Class 2, meaning it poses moderate risk and requires 510(k) premarket clearance demonstrating substantial equivalence to a legally marketed predicate device. The product code is HIR, regulated under 21 CFR 884.1425, within the Obstetrics/Gynecology medical specialty, reviewed by the Genitourinary panel. No special risk flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
    Vaginal Tactile Ultrasound Imager
    Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
    Perifit Care+
    Perifit
    leva Pelvic Health System
    Flyte
    Leva Pelvic Health System
    Flyte
    Intimate Rose Kegel Exercise System
    Pelvital System
    LEva Pelvic Digital Health System
    leva Pelvic Floor Trainer
    Feminine Personal Trainer (FPT)
    Vibrance Pelvic Trainer
    PeriCoach OTC
    Vaginal Tactile Imager
    PeriCoach
    VIBRANCE KEGEL DEVICE (VKD)
    IEVA REHABILITATIVE POSITIONAL DEVICE
    KEGEL SMART, KEGELSMART PEARL
    INNER PEACE
    NATRATONE
    EXTT-101
    KEGELMASTER 2000
    GYNEFLEX
    PELVICFLEXER EXERCISE DEVICE
    INCARE PELVIC FLOOR THERAPY SYSTEM
    INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
    PELVEX HOMETRAINER
    PERIFORM PERINEOMETRIC PROBE, MODEL 8300
    PELVIC MUSCLE THERAPY
    SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
    REFLEX TREATMENT SYSTEM
    FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
    PERIFORM
    PERITRON PERINEOMETER MODEL 9300V OR 9300A
    PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
    PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
    PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
    PERINEOMETER
    PERITRON
    INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
    MYOTRAC2D/CS
    PERIPUMP
    TE-800 PELVIC FLOOR EXERCISER
    ELITE BIOFEEDBACK
    THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
    INCONTROL
    INNOVA VAGINAL EMG SENSING ELECTRODE

    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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