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: MGP FDA unclassified

    Dressing, Wound And Burn, Occlusive

    Unknown

    View full classification →

    The occlusive wound and burn dressing carries an unclassified (Class U) FDA designation, meaning its classification has not been formally determined. It is a wound care device that creates a moist, sealed environment over wounds and burns to promote healing and protect against environmental contamination. The product code is MGP and no regulation number or formal medical specialty has been assigned. It is not implanted and does not sustain life.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    COLLATEK FOAM
    COLLATEK SHEET
    LASERSKIN DRESSING
    FASTSEAL CHEST WOUND DRESSING
    SIMPLICARE TRANSPARENT WOUND DRESSING
    DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
    GILTECH PLUS TRANSPARENT DRESSING
    DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
    DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
    MEPITEL NON ADHERENT SILICONE DRESSING
    INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
    TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
    MODIFICATION TO TIELLE HYDROPOLMER DRESSING
    MEPILEX
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
    BTF THIN FILM WOUND DRESSING
    CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
    INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
    SIMPLICARE THIN FILM WOUND DRESSINGS
    SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
    N-TERFACE
    ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
    3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
    SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
    TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
    HYDRASORB STERILE DRESSING
    LYOCELL WOUND DRESSING/SURGICAL SPONGE
    OPPORTUNITY I.V. START KIT
    ALGOPLAQUE HYDROCOLLOID DRESSING
    NASP TRANSPARENT DRESSING
    SPYROFLEX PIGMENTED WOUND DRESSING
    EPIVIEW
    BIO-DRESSING, STERILE ISLAND DRESSING
    DERMASEAL
    SURESKIN STANDARD
    SURESKIN BORDER
    SURESKIN THIN
    DUKAL TRANSPARENT WOUND DRESSING
    SPYROCOLLOID WOUND DRESSING
    SPYROFLEX SKIN PROTECTOR
    FLEXZAN WOUND DRESSING
    DERMAGRAN HYDROPHILIC WOUND DRESSING
    TECNOL ISLAND WOUND DRESSING
    UNI-SITE
    SPYROFLEX WOUND DRESSING
    TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING
    TECNOL TRANSPARENT WOUND DRESSING
    MITRAFLEX WOUND DRESSING WET-STICK

    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