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

    BAROguard Donor Lung Preservation System

    K Number: K254305 · Decision Jan 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    30

    Basic Information

    Device Name
    BAROguard Donor Lung Preservation System
    K Number
    K254305
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Paragonix Technologies, Inc.
    Date Received
    December 31, 2025
    Decision Date
    January 30, 2026
    Product Code
    KDN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDN System, Perfusion, Kidney

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