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510(k) Data Aggregation

    K Number
    K251888

    Validate with FDA (Live)

    Device Name
    VPAP Pediatric Face Mask
    Manufacturer
    Hsiner Co., Ltd.
    Date Cleared
    2026-03-12

    (265 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    7 - 120
    Reference & Predicate Devices
    K102120,K101129
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K102120

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

    The mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency.

    The mask is for single patient use in the hospital/institutional environment only.

    The mask is to be used on patients 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

    Device Description

    The VPAP Pediatric Face Mask is designed for pediatric patients in hospital and institutional settings, serving as an interface for Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure (BiPAP) therapy. Available in two sizes to accommodate varying facial dimensions of pediatric patients, these masks ensure a comfortable and secure fit. The VPAP Pediatric Face Mask is intended for single-patient, supporting consistent and reliable noninvasive ventilation.

    AI/ML Overview

    N/A

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