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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: HIB FDA class 2

    Speculum, Vaginal, Nonmetal

    Obstetrics/Gynecology

    View full classification →

    The Nonmetal Vaginal Speculum is a gynecological instrument made of plastic or other non-metallic material used to dilate the vaginal canal and expose the cervix for visual examination, specimen collection, or minor procedures during pelvic examinations. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty, subject to premarket controls. The product code is HIB, regulated under 21 CFR 884.4530. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BRELLA-SPEC(TM) VAGINAL SPECULUM
    IOB DISPOSABLE SPECULUM
    CLEARSPEC SINGLE USE VAGINAL SPECULUM
    SPECULUM, VAGINAL, NONMETAL
    KOLPLUX SYSTEM
    NON-STERILE DISPOSABLE VAGINAL SPECULUM
    OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
    MEDLINE DISPOSABLE VAGINAL SPECULUM
    DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
    KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
    HIERSPEC SPECULUM
    IGS VAGINAL SPECULUM
    G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
    FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
    YUSHENG DISPOSABLE VAGINAL SPECULUM
    DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
    GONGDONG DISPOSABLE VAGINAL SPECULUM
    FEMSPEC DISPOSABLE VAGINAL SPECULUM
    VAG O SPECULUM, MODELS VS1, VM1, VL1
    POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
    KENTEX DISPOSABLE VAGINAL SPECULUM
    KAISHOU VAGINAL SPECULUM
    VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    TAGG DISPOSABLE VAGINAL SPECULUM
    CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
    GLO-SPEC I, II AND III
    LEESPEC DISPOSABLE VAGINAL SPECULUM
    DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
    DRG DISPOSABLE VAGINAL SPECULUM
    GLOBAL HEALTHCARE VAGINAL SPECULUM
    GLO-SPEC
    NU-SPEC D
    VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
    (DISPOSABLE) VAGINAL SPECULUM
    MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
    MEDISUL DISPOSABLE VAGINAL SPECULUM
    WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
    PATTON SPECULUM
    GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
    MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303
    VITALCARE DISPOSABLE VAGINAL SPECULUM
    KOLPLAST VAGINAL SPECULUM
    HOSPITAL'S SPEC
    PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS
    NYLON COATED SPECULA
    EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
    VERSA-VU
    AMSINO DISPOSABLE VIGINAL SPECULUM
    KLEENSPEC
    THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV

    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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