BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UNIVERSAL I.V. HOLDER

    K Number: K821317 · Decision May 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    24

    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
    UNIVERSAL I.V. HOLDER
    K Number
    K821317
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Georgetown Medical Co.
    Date Received
    May 4, 1982
    Decision Date
    May 28, 1982
    Product Code
    KMK
    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
    KMK Device, Intravascular Catheter Securement

    Similar 510(k) Clearances

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

    SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F

    FDA 510(k)
    FDA Class 1 ·General Hospital

    A P HARNESS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MULTI-PURPOSE MEDICAL TUBE HOLDER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SECURE-SITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STATLOCK CV

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IV START KITS

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all