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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: KPI FDA class 2

    Stimulator, Electrical, Non-Implantable, For Incontinence

    Gastroenterology, Urology

    View full classification →

    This device is a non-implantable electrical stimulator used to treat urinary or fecal incontinence by delivering controlled electrical impulses to pelvic floor muscles or nerves to restore continence. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPI, regulated under 21 CFR 876.5320 within the Gastroenterology and Urology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Levina Pelvic Floor Muscle Stimulator (RS-48)
    BTL-398
    Pelvic Floor Stimulator (Intrelief PFE)
    StarFormer
    Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
    Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
    Unicare (K-UNICARE-USA)
    MFG-05
    Pelvic Floor Muscle Stimulator
    Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
    Biofeedback Nerve and Muscle Stimulator
    Keffort (MC-100, MC-100A)
    Everyway Incontinence Stimulation System
    Incontinence Probe
    MyOnyx System
    InMode System with vTone Applicator
    Perfect PFE
    ApexMV
    HPM-6000UF
    Incontinence Treatment Device, Model LT2061
    Pelvifine Pelvic Muscle Trainer
    Everyway Incontinence Stimulation System
    HPM-6000U
    Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
    Yarlap II
    Urinary Incontinence System
    YARLAP
    TensCare KegelFit
    ApexM
    InTone
    ELECTRODE FOR URINARY INCONTINENCE
    APEX
    INTONEMV
    INTONEMV
    LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
    INWAVE
    INCONTROL
    TENSCARE ITOUCH SURE MODEL ITS
    OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
    NUTRAC PELVATOR, MODEL PEL 200
    KEGEL8 PELVIC EXERCISER, MODEL OPH 400
    UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
    MYOTRAC INFINITI ELECTRICAL STIMULATOR
    SKYLARK URO PROBE
    EVADRI BLADDER CONTROL SYSTEMS
    ATHENA PELVIC MUSCLE TRAINER II
    ELPHA 4 CONTI
    PATHWAY STM-10 PELVIC FLOOR STIMULATOR
    ATHENA PELVIC MUSCLE TRAINER
    PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM

    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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