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510(k) Data Aggregation

    K Number
    K251674
    Device Name
    Fenom Flo™ FeNO Monitoring System
    Manufacturer
    Mgc Diagnostics Corporation
    Date Cleared
    2025-11-26

    (180 days)

    Product Code
    MXA
    Regulation Number
    862.3080
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K042758,K213611
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fenom Flo™ FeNO Monitoring System is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. Fenom Flo measures fractional exhaled nitric oxide (FeNO) according to guidelines established by the American Thoracic Society.

    Measurement of FeNO by Fenom Flo is a non-invasive quantitative method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels. FeNo measurements are to be used as an adjunct to established clinical assessments. Fenom Flo is suitable for adults and children ages seven years and older.

    Fenom Flo should be used in a point-of-care healthcare setting under professional supervision. Fenom Flo should not be used in critical care, emergency care, or anesthesiology.

    Device Description

    Fenom Flo™ FeNO Monitoring System quantitatively measures fractional exhaled nitric oxide (NO), an important marker for airway inflammation in exhaled human breath.

    The system consists of:

    • A handheld FeNO monitoring device (hereafter referred to as "Fenom Flo Device" or "Device") that houses a rechargeable lithium-ion battery, a nitric oxide sensor, and integrated pneumatics and electronics for breath analysis. The device supports secure wireless communication through dedicated hardware and firmware.

    • A Point-Of-Care Application (hereafter referred to as a "POC App") operating on a Windows platform serves as the primary interface for displaying FeNO scores in parts per billion (ppb). The POC App offers key features, including test initiation, viewing of current and historical results, quality control, adjustable settings, a patient tutorial, and activity and error tracking. The POC App operates on any healthcare provider's (HCP's) device running Windows 10 or 11. It is the HCP's responsibility to ensure that the device on which the POC App is installed meets all necessary performance, security, and compatibility requirements.

    • A single-patient use, non-sterile disposable mouthpiece with an antibacterial/antiviral filter to prepare the exhaled breath for the measurement. The manufacturer is Polytechnic Resources, and the FDA clearance reference is K042758.

    • The power supply recharges the battery or enables the device to operate.

    AI/ML Overview

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