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

    Steripath Gen2 Blood Collection System

    K Number: K192247 · Decision Feb 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    193

    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
    Steripath Gen2 Blood Collection System
    K Number
    K192247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Magnolia Medical Technologies, Inc.
    Date Received
    August 19, 2019
    Decision Date
    February 28, 2020
    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

    Similar 510(k) Clearances

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

    Female Culture Device; Male Culture Device; Transfer Device; Access Device

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Steripath® Flow™ Blood Collection System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Magnolia Medical Technologies, Inc.

    K Number Device Name
    K200661 Steripath Micro Blood Collection System