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510(k) Data Aggregation

    K Number
    K251448

    Validate with FDA (Live)

    Date Cleared
    2026-01-16

    (252 days)

    Product Code
    Regulation Number
    868.5450
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flexicare FL-10000U Respiratory Humidifier is intended to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance via an endotracheal tube or face mask. For use by trained personnel only within a hospital/institutional environment. This device is intended to be used with the Flexicare Autofill Humidification Chamber and Flexicare Heated Wire Breathing Circuit.

    Device Description

    FL-10000U is an electrically powered Respiratory Humidifier that actively conditions the inspired respiratory gases delivered to ventilated patients and those receiving respiratory support. It is used as part of a complete system including a Humidification Chamber and either a heated wire breathing system.

    FL-10000U Respiratory Humidifier is used with patients who require mechanical ventilation or positive pressure breathing assistance via an endotracheal tube and/or face mask.

    The heater plate warms the water in the Humidification Chamber installed on to the top of the device. Gases are warmed and gain humidity in the form of water vapor as they travel along the breathing circuit on the to the patient.

    AI/ML Overview

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