BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Swift Ray 1

    K Number: K251678 · Decision Feb 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    270

    Basic Information

    Device Name
    Swift Ray 1
    K Number
    K251678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Swift Medical, Inc.
    Date Received
    May 30, 2025
    Decision Date
    February 24, 2026
    Product Code
    QJF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QJF Autofluorescence Imaging Adjunct Tool For Wounds

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