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510(k) Data Aggregation

    K Number
    K171954
    Device Name
    ClearLine IV
    Manufacturer
    Date Cleared
    2018-01-25

    (210 days)

    Product Code
    Regulation Number
    880.5445
    Why did this record match?
    Product Code :

    OKL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the V source and can be used with or without fluid warmers.
    Device Description
    The ClearLine IV™ is a modification to the predecessor device, the AirPurge™ System. Both devices consist of two main components, the control unit and the sterile, single-use disposable cartridge. The control unit is mounted to the I.V. pole using a pole clamp attached to the back of the control unit. The disposable cartridge is loaded onto the control unit and connected to the infusion line between the infusion source and the patient. During infusion, air entering the cartridge will be detected by an ultrasonic sensor in the control unit, which will automatically close the patient line and divert the fluid flow containing the air to the waste collection bag. A second ultrasonic sensor in the control unit monitors the line to the waste collection bag. When both sensors detect liquid again, flow to the patient is resumed.
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    K Number
    DEN080009
    Device Name
    AIRPURGE
    Date Cleared
    2014-03-04

    (1952 days)

    Product Code
    Regulation Number
    880.5445
    Why did this record match?
    Product Code :

    OKL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AirPurge™ System is intended for detection and automatic removal of air in intravenous (I.V.) lines during administration of intravenous solutions, blood and blood products. It is indicated for use in the Operating Room and post anesthesia care areas. The AirPurge™ System is placed distal to I.V. bags using gravity feed or pressure, and may be used with or without fluid warmers.
    Device Description
    The Airpurge System (AirPurge) is intended to detect and automatically remove air from an IV infusion line. Airpurge consists of two main components, the control unit and the disposable unit. The disposable unit (Figure-1a) contains the system fluid path and is a sterile, single-use component. This disposable unit is loaded onto the control unit (Figure-1b). The door of the control unit is then closed. Once the device is connected to the infusion line and primed, it uses an ultrasonic sensor to detect air in the infusion line. When air is detected, the device system closes the patient line and diverts the fluid flow to the waste collection bag. A second ultrasonic sensor detects when the air has been removed from the IV line and causes the controller to return the infusion flow back to the patient.
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