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510(k) Data Aggregation

    K Number
    K241135
    Device Name
    RESPOND(R) Ventilator
    Manufacturer
    CorVent Medical, Inc.
    Date Cleared
    2024-11-13

    (203 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K181166
    Why did this record match?
    Applicant Name (Manufacturer) :

    CorVent Medical, Inc.

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

    The RESPOND(R) Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. The RESPOND(R) Ventilator is intended for pediatric through adult patients weighing at least 38 kg.

    The RESPOND(R) Ventilator is intended for use in a hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities.

    The RESPOND(R) Ventilator is intended for use by qualified, trained personnel under the direction of a licensed clinician.

    Device Description

    The RESPOND® Ventilator is a multi-patient continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen/air to the breathing gas.

    The ventilator provides both pressure control and volume modes of therapy and can provide both invasive and non-invasive ventilation. The device is compatible with both passive HME and heated humidification patient circuits, as well as nebulization with an ultrasonic nebulizer. The ventilator is equipped with an oxygen mixing module, which allows oxygen to be delivered to the patient within a range of 21% to 95% concentration.

    The RESPOND® Ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. RESPOND® is intended for pediatric and adult patients weighing at least 38 kg (84 lbs.) and is intended for use in a hospital including intra-hospital transport, and institutional environments such as long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities. The RESPOND® Ventilator is intended for use by qualified and trained personnel.

    AI/ML Overview

    I am sorry, but the provided text does not contain the requested information about acceptance criteria, device performance, sample size, ground truth, or study details. The document is a 510(k) summary for a medical device (RESPOND® Ventilator), primarily focused on demonstrating substantial equivalence to a predicate device. It discusses the device's indications for use, technological characteristics, and a broad overview of non-clinical performance testing without providing specific acceptance criteria or detailed study results in the format you've requested.

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