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510(k) Data Aggregation

    K Number
    K253939

    Validate with FDA (Live)

    Date Cleared
    2026-01-07

    (29 days)

    Product Code
    Regulation Number
    868.5905
    Age Range
    18 - 999
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K210844

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

    The DeltaWave Nasal Pillow System channels airflow noninvasively to a patient from a noninvasive positive airway pressure device (PAP) such as CPAP, bi-level.

    It is intended for adult patients weighing ≥66lbs (30 Kg), and for whom positive airway pressure has been prescribed. It is intended for single patient reuse in the home and hospital/institutional/sleep center environment.

    Device Description

    The DeltaWave Nasal Pillow System is a non-invasive medical device that directs pressurized air from a Continuous Positive Airway Pressure (CPAP) or Bi-level medical device to the patient. The subject device is a type of medical device prescribed by a physician or authorized professional for patients who have been diagnosed with Sleep Apnea. The subject device is designed to prevent pressure drop from the CPAP machine to the patient's nasal passages. That is accomplished by maintaining the same, or greater flow space from the machine output to the patient's nostrils. To further ensure the least amount of pressure drop the nasal pillows are designed to gently dilate the patient's nostrils to avoid restrictions to incoming air entering the nostrils. This allows air to enter the patient's nostrils at a lower driving pressure.

    AI/ML Overview

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