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

    Steripath® Flow™ Blood Collection System

    K Number: K251812 · Decision Sep 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    105

    Basic Information

    Device Name
    Steripath® Flow™ Blood Collection System
    K Number
    K251812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Magnolia Medical Technologies
    Date Received
    June 12, 2025
    Decision Date
    September 25, 2025
    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 Magnolia Medical Technologies

    K Number Device Name
    K222299 Steripath Micro Blood Collection System