BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LIA-1 Catheter (542-1)

    K Number: K251402 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    227

    Basic Information

    Device Name
    LIA-1 Catheter (542-1)
    K Number
    K251402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leadoptik, Inc.
    Date Received
    May 6, 2025
    Decision Date
    December 19, 2025
    Product Code
    KTI
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KTI Bronchoscope Accessory

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