BEUDAMED
    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: HIS FDA class 2

    Condom

    Obstetrics/Gynecology

    View full classification →

    A condom is a barrier contraceptive device worn over the penis during sexual intercourse to prevent pregnancy and reduce the transmission of sexually transmitted infections. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing in the United States. The product code is HIS, regulated under 21 CFR 884.5300, within the Obstetrics/Gynecology medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Natural rubber latex male condom
    Lelo Hex Lubricated Natural Rubber Latex Condom
    Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
    0.04 ZERO ZERO FOUR Male Latex Condom
    LifeStyles NRL Textured Condom
    SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
    Male Latex Condoms
    Durex Patronus CloseFit, Durex Patronus Regular
    Durex Penck III Regular
    TROJAN Fire & Ice lubricated male natural rubber latex condom
    FAMA Male Latex Condoms
    TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
    Durex Condom with Benzocaine
    Microthin Natural Rubber Latex Condom
    Titan Condoms
    Durex Patronus Wide
    SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
    Playboy 3 Contour Condom
    One Touch Spiral Condom
    Male Latex Condom
    SKORE (Colors & Flavors), SKORE (Colors)
    Durex Penck Standard, Durex Penck XL
    Non-spermicidal Lubricated Male Latex Condom
    CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
    Extremely Thin 003, ZERO ZERO THREE
    One Touch
    Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
    One Touch Condom with Benzocaine
    JUD custom fit condom
    Male Latex Condoms
    Lifestyles Zero Lubricated Latex Male Condom
    LELO RESPECT HEX Natural Rubber Latex Condom
    aoni Natural Rubber Latex Condom
    Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
    Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
    Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
    Lelo Hex Natural Rubber Latex Condom
    O-RING Condom
    Banana Gold
    TheyFit Male Condom
    SKORE AND MULTIPLE BRANDS
    NATURAL RUBBER LATEX MALE CONDOMS
    OKAMOTO STUDDED CONDOM
    MEGA BIG BOY CONDOM
    SUSTAIN
    INSTINCT; PLAIN, DOTTED, ULTRA THIN
    MALE LATEX CONDOM
    BLACK COLOURED CONDOM
    TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
    THEYFIT MALE CONDOM

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump