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510(k) Data Aggregation

    K Number
    K251676
    Device Name
    Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
    Manufacturer
    Microtek Medical LLC
    Date Cleared
    2025-09-16

    (109 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182819
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Microtek decanters are intended for the aseptic transfer of solutions (eg. IV fluids and medications) from IV containers

    • Bag decanters are for use in transferring IV fluids and medication from a bag to an IV fluid administration device.
    • Vial decanters are for use in transferring IV fluids and medications from a vial to an IV fluid administration device.
    • Transfer devices are for use in transferring IV fluids and medications from a vial or medication container to an IV fluid administration device.

    Microtek decanters are suitable for adult and pediatric patients. The use of decanters is at the discretion of the healthcare professional.

    Device Description

    Microtek decanters and transfer devices are provided sterile and for use in a single procedure only. They consist of a hollow tube with protective removable caps at either end. The injection molded hollow tube has at least one spiked end used to access the source container to initiate fluid transfer. The vial decanter includes a built-in splash guard.

    Decanters and transfer devices are designed to transfer medical fluids (e.g.: medications and solutions) between various containers.

    Model Number(s)DescriptionContainer ConfigurationOverall Length (of finished device without caps)Materials
    2000SC-Flo Bag Decanter, SterileBag to an IV fluid administration device8.25"PMMA
    2002SBag Decanter II, SterileBag to an IV fluid administration device8.25"HIPS825
    2006SVial Decanter, SterileVial to an IV fluid administration device6"HIPS825, ABS
    2008STransfer Device, SterileVial or medication container to an IV fluid administration device3"ABS
    AI/ML Overview
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