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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.

    Let the assistant find your predicates

    Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples
    Product Code: FZT FDA class 1

    Cutter, Surgical

    General, Plastic Surgery

    View full classification →

    The Cutter, Surgical (product code FZT) is a general-purpose manual cutting instrument used in surgical procedures to incise, divide, or trim tissue during general or plastic surgery. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 within the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SMARTSHEARS
    AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
    MICRINS SURGICAL SCISSOR
    SINGLE HAIR TRANSPLANT GRAFT
    SPC DISPOSABLE CUTTER
    SCISSORS, VARIOUS
    SURGICAL SCISSORS, SET OF 3
    CONPHAR IRIS SCISSORS
    CONPHAR LITTAUER SCISSORS
    CONPHAR DISSECTING SCISSORS
    CONPHAR TONSIL SCISSORS
    CONPHAR WIRE CUTTING SCISSORS
    CONPHAR SCISSORS 4&1/2 SHARP BLUNT
    OPERATING SCISSORS 4 & 1/2 BLUNT/BLUNT
    CONPHAR SCISSORS 4&AHALF SHARPSHARP
    SCISSORS CURVED 4 & 1/2 SHARP
    OPERATING SCISSORS CURVED 4 & 1/2 BLUNT
    OPERATING SCISSORS 5 &1/2 SHARP BLUNT&
    LISTER BANDAGE SCISSORS 3 & 1/2
    LISTER BANDAGE SCISSORS 7 & 1/2
    OPERATING SCISSORS CURVED 6 & 1/2 SHARP
    SCISSORS STRAIGHT 5&1/2SHARP
    OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT
    SCISSORS 6 & 1/2 SHARP/BLUNT
    SCISSORS 5 & 1/2STRAIGHT BLUNT/BLUNT
    LISTER BANDAGE SCISSORS 5 & 1/2
    OPERATING SCISSORS 5&1/2 CURVED SHARP
    BANDAGE SCISSORS 4 & 1/2
    MED-CARE EMERGENCY SHEARS
    SUTURE REMOVAL PAK
    SURGICAL STITCH CUTTER
    SCISSOR'S #'S 2294,2262,2263
    BROOKS GALL BLADDER SCISSORS (SURG)
    FLOOR LINE INSTRUMENTS
    SURGICAL INSTRUMENTS HEIFETZ DIGITATE
    COLOR CODING OF SURGICAL INSTRUMENTS
    ITIMIZED INSTRUMENTS
    SUTURE CUTTER
    LASCHAL SCISSOR
    FACELIFT SCISSORS
    LAPAROSCOPY DRAPE, BOUNDARY
    THOREK SCISSORS 7 1/4 & 10
    SURG. SCISSORS FOR CUTTING TISSUE
    SCISSORS, SURGICAL, 12.5,14,16 & 18 CM.
    SCISSORS, SURGICAL, ANGULAR, 14 CM.
    SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM.
    SCISSORS, BANDAGE, 15,18,20CM., ANGULAR
    CUTTER, P605 GENERAL PURPOSE
    CUTTER, P606 BONE
    NIPPER, NAIL, P610 ENGLISH

    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
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