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510(k) Data Aggregation

    K Number
    K141009
    Device Name
    FORT DEFIANCE AUTOMATED STEAM STERILIZER
    Date Cleared
    2014-12-16

    (242 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fort Defiance Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fort Defiance Industries, Inc. Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments.
    Device Description
    The Fort Defiance Industries, Inc. model P2131 sterilizer is an automated steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 is a pre-vacuum and post-vacuum sterilizer that has a conditioning stage with vacuum air removal before the start of the exposure stage, as well as a post-exposure drying stage that is based on the combined operation of heat plus vacuum. The sterilization agent is steam that is electrically-generated in a jacketed boiler. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer, (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS). The WRS reclaims hot condensate and exhaust steam for re-use by the sterilizer. The WRS also includes a water eductor, which provides the vacuum capability for the pre and post-vac phases of sterilization. The Sterilizer Water Softener (SWS) filters and de-mineralizes the incoming water to prevent scale build-up. The P2131 is an automated, microprocessor-controlled, prevacuum autoclave. It has a fully-jacketed, horizontal-type pressure vessel. The P2131 is of welded aluminum alloy construction to minimize weight. The chamber assembly, with internal dimensions of 16" diameter x 36" long, is supported in a combination frame and endcap assembly to provide rigidity and protection. These endcaps, when closed, completely enclose and protect the sterilizer and its heat source providing the capability to serve as a shipping container. When the endcaps are opened they provide an integral stand, placing the sterilizing chamber and operating controls at a convenient working height.
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