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510(k) Data Aggregation

    K Number
    K130023
    Device Name
    K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
    Manufacturer
    NP MEDICAL, INC.
    Date Cleared
    2013-04-03

    (90 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NP MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K100 Neutral Displacement Connector is a single patient use, sterile, non-pyrogenic device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
    Device Description
    The K100 Neutral Displacement Needleless Connector is a sterile, single patient use, swabable, normally closed, luer-activated, valved connector. The K100 valve is comprised of a: a housing (inlet and outlet), a fluid channel, a translating member (or lower gland) secured to a longitudinal wall of the housing and bounding a variable volume region of the fluid channel, a post having a lumen terminating at a distal head of the post and biased in the proximal direction by the lower gland when in the closed mode, and an upper seal having a sealing ring and secured to the longitudinal wall of the housing, the sealing ring contacting the distal head of the post when in the closed mode to prevent flow through the fluid channel, Moving components within the assembly are lubricated with silicone oil.
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    K Number
    K973916
    Device Name
    NP MEDICAL CAPLESS LUER ACTIVATED VALVE
    Manufacturer
    NP MEDICAL, INC.
    Date Cleared
    1998-03-09

    (146 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NP MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Capless Luer Activated Valve, incorporating a luer activated valve, is intended for use in facilitating needleless fluid delivery and may be swabbed with antiseptic just prior to use, thereby eliminating the need for capping between uses.
    Device Description
    The Capless Luer Activated Valve is a two-part device consisting of a Gland Housing Assembly and a Gland/Center Post Assembly, as described below: The Gland is a valve/gasket which provides a seal against the syringe/luer connector when the device is being utilized. The Gland incorporates a slit to accept the syringe/luer connector. The Gland is also the swabbable surface of the Capless Luer Activated Valve. The valve can be easily swabbed per hospital protocol before each connection. The Center Post mechanically supports the Gland and serves as the primary high pressure seal to keep the fluid path closed during the resting state. The Gland and the Center Post are mechanically press-fit together to form the Gland/Center Post Assembly. In the resting state, the Center Post is flush with the walls of the Gland Housing, ensuring that there is no fluid path. As the device is activated by a syringe/male luer connector, the flexible Gland is forced open and the Center Post is pushed down. As the Center Post is forced further down into the Gland Housing, the fluid path is established.
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