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510(k) Data Aggregation

    K Number
    K191858
    Device Name
    Pylant Monitor
    Manufacturer
    Kal-Med LLC
    Date Cleared
    2020-02-24

    (228 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kal-Med LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.
    Device Description
    The PYLANT MONITOR is used by personnel trained in pulmonary resuscitation and airway management (ex. anesthesiologists, RN, respiratory therapists, EMT, paramedics) used to measure the trachael cuff pressure of an endotrachael tube or tracheotomy tube by measuring the external pilot line port of the tube. The Pylant Monitor (PM) is a medical device intended to indicate changes inside an endotracheal tube (ETT) cuff. One end of the PM is fabricated to fit into the "pilot balloon" (international standard for all types of intra-tracheal tubes with a cuff) of the ETT cuff. The other end is fabricated to accept a medical syringe (international standard for all intravenous syringes) for adding or removing air from inside the ETT cuff and altering the volume of air and therefore the pressure inside the ETT cuff. The syringe end of the PM has a one way air tight valve that is open when the syringe is connected. When the syringe is not connected the valve is closed and air is trapped within the ETT cuff and the PM creating the seal between the trachea and cuff. In between the two ends of the PM is a silicone diaphragm that expands and contacts with pressure. As pressure rises the more the diaphragm expands and as pressure falls the diaphragm contracts. Attached to the center of the diaphragm is and indicator arrow/needle. The diaphragm and arrow/needle is housed inside a designed case. The case acts as a protector of the silicone diaphragm arrow needle assembly and is labeled, color coded and calibrated to indicate pressure ranges from 20 cm H2O to 30 cm H2O. The PM is designed to remain connected to the ETT pilot balloon and continuously monitor the pressure or monitor pressure intermittently. Pressure changes within the ETT when connected to the PM are indicated by expansion or contraction of the silicone diaphragm causing calibrated movement of the arrow/needle and indicated on the color coded label.
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