BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    K-SHIELD Zen

    K Number: K220799 · Decision Aug 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    5
    Review Days
    164

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    Basic Information

    Device Name
    K-SHIELD Zen
    K Number
    K220799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sb-Kawasumi Laboratories, Inc.
    Date Received
    March 18, 2022
    Decision Date
    August 29, 2022
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Sb-Kawasumi Laboratories, Inc.

    K Number Device Name
    K252355 K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
    K241855 SB Knife Jr2 (MD-47702 and MD-47702L)
    K230408 K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
    K223810 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)