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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: KCT FDA class 2

    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    General Hospital

    View full classification →

    Sterilization wrap containers, trays, cassettes, and related accessories are devices used to package, protect, and maintain the sterility of surgical instruments and other reusable medical devices during sterilization processes and subsequent storage until point of use. They are classified as FDA Class 2 devices, indicating moderate risk, and require 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. Product code KCT is regulated under 21 CFR 880.6850 in the General Hospital medical specialty. This device is eligible for third-party review under FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PAL Sterilization Case
    Aesculap Aicon® Series Container System
    ONE TRAY® Sealed Sterilization Container System
    Synthes Graphic Case & Tray System
    Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
    Microdent Sterilization Cassette
    NUVENTUS NV.C™ Surgical Cassette and Tray
    System 9 Sterile Battery Container
    Klockner Kits
    Guided Surgery Kit Cases
    SteriTite rigid reusable sterilization container with MediTray Products
    CrossRoads Modular Tray System
    S.I.N. Instrument Kits
    Perforated Baskets
    BAHADIR STERILIZATION CONTAINERS
    Washtrays
    Anthogyr INTEGRAL Guided Surgery Cassettes
    Aygün Sterilization Container Systems
    Instrument Case
    PRO-LITE Sterilization Tray
    Anthogyr Surgical Cassettes
    Complement Kit Cases
    NobelZygoma PureSet™ Tray
    Sweden & Martina Surgical Trays
    Neodent Implant System - Helix Short Surgical Kit Cases
    Instrument Case P1340904
    Aesculap AICON Container
    S.I.N. Instrument Kits
    SteriTite Container System with MediTray Parts
    S.I.N. Instrument Kits
    SteriCUBE® Multiple Tray Sterilization Systems
    Surgical and Prosthetic Trays
    SteriTite Container System with MediTray Products
    Neodent Implant System-Helix NGM Compact Surgical Kit Cases
    Surgical Trays
    Southern Implants Instrument Trays
    Sterisystem Dry-Base Instrument Tray
    EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
    TCAT TKA Instrument Tray
    Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray
    InstruSafe Instrument Protection System
    Biotech Dental Kits
    S.I.N. Instrument Kits
    UroLift System Rigid Retrieval Kit Sterilization Tray
    Instrument tray, for semi-rigid ureteroscope
    Straumann Surgical Cassettes
    KARL STORZ Metal Sterilization Trays
    EZ-TRAXTM Persona Knee Containment Device
    Karl Storz Radel Sterilization Trays
    ST-Z5

    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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