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

    ACTIV™ Cap

    K Number: K223914 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    463

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACTIV™ Cap
    K Number
    K223914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cleansite Medical, Inc.
    Date Received
    December 29, 2022
    Decision Date
    April 5, 2024
    Product Code
    QBP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QBP Cap, Device Disinfectant

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QBP), ordered by most recent decision date.

    OTTO™ Disinfecting Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SteriHub™ Disinfecting Device and Protective Cover

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PureHub Disinfecting Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Curos Jet Disinfecting Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CapKlenZ

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SwabTip Male Disinfectant Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all