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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: FRO FDA unclassified

    Dressing, Wound, Drug

    Unknown

    View full classification →

    A drug wound dressing is a wound care product that incorporates a pharmaceutical agent intended to promote healing, prevent infection, or manage wound exudate. This product is currently unclassified by the FDA, meaning its classification has not been finalized; it is under review by the General, Plastic Surgery panel. The product code is FRO and no regulation number has been assigned. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Bonvadis®
    StatSeal Disc
    IWD-Gel™
    MiraChlor Antimicrobial Wound Solution
    Promogran Prisma™ Collagen Matrix with ORC and Silver
    LUOFUCON® Antimicrobial Wound Gel
    Redermax Antibacterial Wound Matrix
    New Day Skin Spray
    SBC1 Cream
    revyve® Antimicrobial Skin and Wound Cleanser
    Puracyn® Plus Antimicrobial Irrigation Solution
    Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
    LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
    Hemastyl(™) Wound Dressing
    Tegaderm Post-Op Transparent Antimicrobial Dressing
    Dermalage
    Granudacyn® Wound Irrigation Solution
    Bonvadis®
    Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
    Spectricept Skin and Wound Cleanser
    SiOxC Cream
    Sterile Water USP and Sterile 0.9% Normal Saline USP
    LUOFUCON® Silver Collagen Dressing
    Atrauman® Ag
    LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
    Microdacyn Hydrogel
    Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
    Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
    Microlyte Ag/Lidocaine
    LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
    Derma-R Cream (Derma-R Cream)
    Microdacyn Wound Care Solution
    Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
    Silverlon® Wound Contact, Burn Contact Dressing
    coactiv+™ Antimicrobial Wound Gel
    Field Shield Wound Dressing
    Irrisept Antimicrobial Wound Lavage
    Puracyn® Plus Antimicrobial Irrigation Solution
    Anti-bacterial bandage
    ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
    Bonvadis®
    LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
    PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
    Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
    Copper Foam Dressing (Prescription and OTC)
    LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
    LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
    Antibacterial Gel Wound Dressing
    Polyver Silver Alginate Dressing (Prescription and OTC)
    Skin and Wound Cleanser

    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

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