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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: FSM FDA class 1

    Tray, Surgical, Instrument

    General, Plastic Surgery

    View full classification →

    A surgical instrument tray is a container used in the operating room to hold and organize surgical instruments during and between procedures, maintaining order and sterility. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSM, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    INSTRUMENT TRAY LINER
    SINGLE USE INSTRUMENT TRAY
    SURGICAL INSTRUMENT TRAY
    ARTHROSCOPY TRAY
    OPEN HEART TRAY
    HEART CATH TRAY
    MAJOR BASIN TRAY
    SPLINTER TWEEZERS
    REDDICK TROCAR AND CANNULA
    KEY COMFORT GRIPS
    RICHARD-ALLAN CLAMP COVERS
    HAND SURGERY AND IRRIGATION TRAY (MODEL 3625)
    CUSTOM TRAYS, KITS
    STERILE LACERATION TRAY CAT. #749
    THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM
    CASF STERILIZATION TRAY
    CASF STERILIZATION TRAY
    BREVET CASSETTE STERILIZATION MODULE
    STERILIZATION TRAY, TMJ INSTRUMENT SET
    SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS
    MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
    RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY
    SCANLAN (TM) INSTRUMENT TRAY
    INSTRUMENT STERILIZATION TRAY
    SURGICAL LASER ACCESSORIES (SLA) CASE
    VENESECTION EQUIPMENT STORAGE TRAY
    SURGICAL PACKS, KITS AND TRAYS
    DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS
    OPERATING ROOM TRAY
    SURGICAL INSTRUMENT TRAY
    GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR
    C.A.S.E. CONTAINER
    VENESECTION TRAY, ADULT 6050
    FLASH GUARD PLASTIC VERSION
    HU-FRIEDY IMS CASSETTE SYSTEM
    MSI SURGI-GRADE SUTURE TRAY
    MSI SURGI-GRADE UNIVERSAL TRACH TRAY
    ABDOMINAL PARACENTESIS TRAY
    MSI SURGI-GRADE INCISION & DRAIN TRAY
    STERILE INSTRUMENT TRAYS-VARIOUS
    VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
    TRACHEOSTOMY CARE TRAY
    OPERATING ROOM TRAY SET
    GEN. PURPOSE INSTRUMENT TRAYS &
    CONVERTORS FLASH STERILIZING TRAY
    VARIOUS INSTRUMENTS & INSTRUMENT TRAYS
    MEDCARE SUTURE REMOVAL TRAYS
    MEDCARE GENERAL PURPOSE TRAY
    HANDI-TRAY
    MEDCARE WOUND CLOSURE TRAY

    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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