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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: HHW FDA class 2

    Pessary, Vaginal

    Obstetrics/Gynecology

    View full classification →

    The Vaginal Pessary is an intravaginal supportive device, typically made of silicone or rubber, inserted into the vagina to mechanically support prolapsed pelvic organs or to manage stress urinary incontinence in women who are not surgical candidates or prefer conservative management. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHW, regulated under 21 CFR 884.3575, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes
    CooperSurgical Milex® Pessaries
    Cntrl+ Bladder Support Pessary
    Reia pessary
    Yoni.Fit Bladder Support
    Uresta®
    Gynethotics™ Pessary
    ProVate Vaginal Support
    Revive Reusable Bladder Support
    Panpac Flexi Shelf Pessary
    Panpac Disposable Pessary Fitting Set
    Always/Tampax bladder supports
    PESSARY
    PANPAC INFLATABLE DOCUT PESSARY
    TIPI OTC
    PANPAC VAGINAL PESSARY
    MODIFICATION TO URESTA PESSARY
    URESTA PESSARY
    TIPI
    KOLPEXIN SPHERE
    MARINA MEDICAL SILICONE PESSARY
    MTI ST#1 SILICONE PESSARY
    PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
    BIOTEQUE VAGINAL PESSARIES
    PELVX GELLHORN VAGINAL PESSARY 603-608
    MENTOR EVACARE VAGINAL PESSARIES
    PELVX INCONTINENCE DISH, MODEL 301-306
    PELVX INCONTINENCE RING
    PELVX DONUT, PELVX CUBE
    PELVX RING, PELVX RING WITH SUPPORT
    INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
    VAGINAL CONTINENCE DEVICE
    BLADDER NECK SUPPORT PROTHESIS FITTING KIT
    PESSARY FLEXIBLE SILICONE DONUT RING
    FLEXIBLE SILICONE GELIHORN
    INGLAT-O-BALL
    INFLAT-O-BALL
    GELLHORN PESSARY 33410 VARIOUS SIZES
    FEMALE CONTINENCE DEVICE
    DEVICE, FEMALE INCONTINENCE
    SILASTIC BRAND INTRAVAGINAL TARSETTE

    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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