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510(k) Data Aggregation

    K Number
    K243994
    Device Name
    Steam Sterilizer (2545D)
    Manufacturer
    Ningbo Ican Machines Co., Ltd.
    Date Cleared
    2025-06-06

    (162 days)

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

    Ningbo Ican Machines Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities. (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices). The 2545D was validated for use in: Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.
    Device Description
    The subject device (model: 2545D) is a table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. The 2545D uses steam as a sterilizing agent, produced by warming up a controlled amount of demineralized water which then flows into the chamber as steam. A heating element wrapped around the chamber maintains the required temperatures and steam. All processes are controlled by the device's computerized control system. To use, the operator fills the water reservoir with water (distilled or purified), loads the trays with cleaned instruments, and manually closes the chamber door. The operator then selects the appropriate sterilization cycle on the user interface. Once "Start" is pressed, the sterilizer automatically performs all necessary operations, including Filling, Heating, Sterilization, Venting, and Drying. Sterilization parameters and process status are displayed on the screen. The 2545D is designed with the following external ports and printing functions: - One built-in USB port to enable the operation of an external USB device to record sterilization cycles. - Built-in report printer to print sterilization records. - Built-in memory to record up to 16000 sterilization cycles, which can be exported to a USB device. - Built-in label printer to print labels with a unique cycle ID barcode, Program name, and expiry dates (optional additions). The chamber and door are made of corrosion-resistant 304L stainless steel. It features an LCD Display and touch pad user interface, High Temperature Silicon Rubber door gaskets, a manual door lock, and a door safety interlock. It also has an ASME pressure relief valve and an Overheat Protection (Thermostat@250°C). The device is powered by AC 120V 60 Hz 1750VA. The operation principle is sterilization by heating a controlled amount of demineralized water to generate steam and maintaining its temperature with a heating element. It includes a vacuum mechanism for air removal and drying.
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