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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: HEB FDA class 2

    Tampon, Menstrual, Unscented

    Obstetrics/Gynecology

    View full classification →

    The Unscented Menstrual Tampon is an absorbent intravaginal device designed to collect menstrual fluid during menstruation. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification prior to marketing. The product code is HEB, regulated under 21 CFR 884.5470, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SABA Tampons
    Unscented Tampon
    Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
    TOSAMA Reusable Applicator
    Unscented Menstrual Tampon
    Daye Tampon
    Organic cotton tampon, Viscose tampon
    Sequel Tampon with Plastic Applicator
    U by Kotex® Click® Unscented Menstrual Tampons
    Unscented Menstrual Tampon
    Tempo Tampon
    Cohitech Cottonlock Tampons with Reusable Applicator
    Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
    Cohitech Reusable Tampon Applicator
    Tempo Natural Tampon
    Callaly Tampliner (super plus absorbency)
    Every Cycle Reusable Tampon Applicator
    Callaly Tampliner
    Callaly Tampliner
    Youjia Unscented Tampon with Plastic Applicators
    Unscented W long plastic and cardboard applicator tampons
    Interlude Rolled Tampons in Plastic Applicator
    FEMME Applicator Tampon
    CottonDay Tampon
    Rael Tampon
    Unscented Menstrual Tampon
    COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
    Interlude 100% Cotton Tampon
    re.t.a Reuseable Tampon Applicator
    Interlude and private label Unscented 3-piece compact applicator tampon
    Playtex Stella Tampons
    Tosama Biobased Applicator Tube Menstrual Tampon
    U by Kotex Click Unscented Menstrual Tampons
    Ontex and other proprietary names
    Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
    COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
    Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
    Tosama 100% Organic Cotton Menstrual Tampon
    Ontex Unscented Tampons with Colored Plastic Applicators
    Tosama 100% Cotton Menstrual Tampon
    ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
    U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
    ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
    TAMPAX M PLASTIC TAMPONS, UNSCENTED
    TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
    VEEDA 100% COTTON MENSTRUAL TAMPON
    ONTEX AND OTHER PROPRIETARY NAMES
    LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
    TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
    U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS

    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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