LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021634
    Device Name
    KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
    Manufacturer
    KING SYSTEMS CORP.
    Date Cleared
    2003-01-09

    (237 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105

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

    The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "KING LTTM" oropharyngeal airway. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot fulfill your request for that specific information based on the text provided. This document is a regulatory approval notice, not a study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1