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

    CorVision® (91-205-Z0014)

    K Number: K260051 · Decision May 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    124

    Basic Information

    Device Name
    CorVision® (91-205-Z0014)
    K Number
    K260051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CorVent® Medical, Inc.
    Date Received
    January 8, 2026
    Decision Date
    May 12, 2026
    Product Code
    MOD
    Advisory Committee
    Anesthesiology
    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
    MOD Accessory To Continuous Ventilator (Respirator)

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