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510(k) Data Aggregation

    K Number
    K253479

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (66 days)

    Product Code
    Regulation Number
    868.5450
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K201723

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

    This product is intended for delivery of respiratory gases to adult patients in hospitals.

    This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals.

    Qualitative carbon dioxide (CO2) sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.

    This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care or airway management.

    This product is not intended for apneic ventilation.

    This product is not indicated for use during CPR.

    Device Description

    The Optiflow™ Switch+ Filtered Nasal Interface with CO2 Sampling interface is intended to deliver respiratory gases to the patient.

    The subject device includes a CO2 sampling tube that provides a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer.

    The subject device has been designed to allow for mask ventilation without the need to remove the nasal interface from the patient during therapy. To support this function, a Flow Diverter (K234053) is required.

    The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.

    This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).

    It is intended to be used in combination with a compatible respiratory humidifier, Optiflow Oxygen Kit and the Optiflow Flow Diverter (K234053).

    AI/ML Overview

    N/A

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