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510(k) Data Aggregation

    K Number
    K111577
    Device Name
    MEDLINE VIAL DECANTER
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2011-09-08

    (93 days)

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

    Decanting device intended for the aseptic dispensing of solutions from IV containers. For use in Docalining at 100 minumedication from a vial to an IV fluid administration device.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Medline Vial Decanter does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

    The document is a clearance letter indicating that the device is substantially equivalent to a legally marketed predicate device. It defines the device, its regulation number, and product code, and states its indications for use. It also provides general information about FDA regulations but does not include details about a performance study with specific acceptance criteria or results.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or other study-related details based on the information given.

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