LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990461
    Device Name
    MCKINLEY SP DISPOSABLE INFUSION PUMP
    Manufacturer
    MCKINLEY, INC.
    Date Cleared
    1999-06-30

    (138 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MCKINLEY SP DISPOSABLE INFUSION PUMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The McKinley SP is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The McKinley SP is also intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.

    Device Description

    McKinley SP Disposable Infusion Pump

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (McKinley SP Disposable Infusion Pump). It states that the device is substantially equivalent to a pre-amendment device but does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
    3. Information about training sets or their ground truth establishment.

    The document primarily focuses on regulatory approval and indications for use, without detailing the performance studies conducted to support the substantial equivalence claim.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1