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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: EYQ FDA class 1

    Garment, Protective, For Incontinence

    Gastroenterology, Urology

    View full classification →

    The protective garment for incontinence is a wearable absorbent product designed to contain urinary or fecal leakage in individuals with incontinence, providing skin protection and maintaining dignity and comfort. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EYQ, regulated under 21 CFR 876.5920 in the Gastroenterology, Urology specialty. This device is GMP exempt.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
    KIT PAK INCONTINENT SKIN CARE KIT
    DEODORIZING AND SOUND MUFFLING ANAL PAD
    LIB SYSTEM, BABY/ADULT DIAPER
    INTERA SHIELD AND INTERA UNDERGARMENT
    DRIPRIDE ULTRA INCONTINENT PAD
    DRIPRIDE PROVIDE SLIM
    REUSABLE ADULT INCONTINENT DIAPER
    DRY COMFORT UNDERGARMENT
    AT EASE STRESS PAD
    AT EASE ADULT DIAPER
    CHICOPEE ADULT INCONTINENCE SHIELDS
    DRIPRIDE PROVIDE ULTRA
    ATTENDS INCONTINENT BRIEF
    MALE URINARY STRESS PAD*
    FREE & ACTIVE(TM) ABSORBENT PADS
    MODIFIED PROTECTIVE GARMENT
    MATTRESS COVER
    MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
    UNITY DISPOSABLE INCONTINENT BRIEF
    DAISY (ABSORBENT INCONTINENCE SHIELD)
    ADAM (ABSORBENT INCONTINENCE SHIELD)
    DEPEND FITTED BRIEF
    ADULT ABSORBENT INCONTINENT BRIEF
    KAY PLUS ADULT DIAPER
    PROTECTIVE PAD FOR INCONTINENCE
    ESTEEM INCONTINENT SYSTEM
    PREFER INCONTINENCE AID
    ATTENDS INCONTINENT UNDERGARMENT
    DIGNITY PANT & ABSORBENT PADS
    ADULT DISPOS. INCONTINENT PANTS
    CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
    TRANQUILITY
    MOLINEA PANTY
    MOLICARE
    MOLINEA INCONTINENT PAD
    ULTRA SHIELD BRIEFS
    AMBEZE DISPOSABLE INCONTINENCE PANTS
    MINIGARD DISPOSABLE LINERS
    MAXISHIELD INCONTINENCE CARE SYSTEM
    SERENITY CONTOURED ABSORBENT SHIELDS
    ABSORBENT INCONTINENT PADS & BRIEFS
    MALE INSERT SLIP
    ADULT INCONTINENCE BRIEF
    ADULT INCONTINENCE PAD
    CONVEEN DRIP COLLECTOR/NET PANTS
    ADULT INCONTINET BRIEF
    INCONTINENCE PAD OR ADULT DIAPER
    INCONTINENT PAD & BELT
    DISPOSABLE ADULT DIAPER

    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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