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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: JCT FDA class 2

    Prosthesis, Tracheal, Expandable

    General, Plastic Surgery

    View full classification →

    An expandable tracheal prosthesis is a surgically implanted device used to restore tracheal patency following resection, injury, or disease, designed to expand within the airway to maintain an open lumen and support respiratory function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JCT, regulated under 21 CFR 878.3720, within the General and Plastic Surgery medical specialty. This device is an implant and is classified as life-sustaining.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    Ultraflex™ Tracheobronchial Stent System
    Through the Scope Tracheal Stent System
    Tracheal Stent System (Y-Shaped)
    Tracheal Stent System
    HANAROSTENT Trachea/Bronchium (CCC)
    AEROmini Tracheobronchial Stent System
    WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
    AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
    BONASTENT TRACHEAL / BRONCHIAL
    ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
    ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
    AERO DV TRACHEOBRONCHIAL STENT SYSTEM
    AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
    ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
    AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
    ATRIUM ICAST COVERED STENT
    ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
    ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
    FLUENCY TRACHEOBRONCHIAL STENT GRAFT
    ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
    MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
    VIATORR ENDOPROSTHESIS
    MODIFICATION TO VIABAHN ENDOPROSTHESIS
    WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
    INTRACOIL SELF-EXPANDING PERIPHERAL STENT
    VIABAHN ENDOPROSTHESIS
    VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
    INTRACOIL STENT
    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
    INTRACOIL PERIPHERAL STENT
    WALLSTENT ENDOPROSTHESIS
    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
    ULTRAFLEX
    WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
    WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
    WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
    GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT

    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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