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510(k) Data Aggregation

    K Number
    K990288
    Device Name
    FREE FLOW SAFETY DEVICE, MODEL MG 245052
    Manufacturer
    TEVA MEDICAL, LTD.
    Date Cleared
    1999-02-24

    (26 days)

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

    For use with any I.V. set assembled on commercially available I.V. pumps (not equipped with free flow protection), in order to prevent free flow of drugs or I.V. fluids.

    Device Description

    Anti Free Flow Valve

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Free Flow Safety Device, Model MG 245052," also referred to as an "Anti Free Flow Valve." The letter confirms that the device is substantially equivalent to a legally marketed predicate device.

    However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is solely a regulatory clearance letter and does not include the detailed technical study information that would typically be part of a 510(k) submission's supporting data.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided input. This document only confirms that the device has received FDA clearance for marketing.

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