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510(k) Data Aggregation

    K Number
    K220736
    Device Name
    Consolidated HC Steam Sterilizer
    Date Cleared
    2022-08-01

    (140 days)

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

    Consolidated Machine Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Consolidated HC Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities using saturated steam as the sterilizing agent. They are equipped with factory programmed cycles. The factory programmed cycles, the chamber and overall dimensions, and the number of standard test items per AAMI ST8:2013 for all models of the HC Series steam sterilizers are provided below.
    Device Description
    The steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam (reference 21 CFR Part 880.6880). Three models have been selected for the Consolidated HC Sterilizer product line: Model 3AV-HC, Model 26AV-HC, and Model 26BV-HC. The sterilizer will be targeted for sale into Ambulatory Surgery Centers (ASCs), Clinics, and Hospitals. The Consolidated HC Steam Sterilizers are for general purpose gravity, vacuum, or liquid steam sterilization of heat and moisture-stabile medical goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive-pressure pulse conditioning and pressure/vacuum pulsing for dynamic air removal. The programmed cycles are easily accessed and are password protected. All cycle phases are sequenced and monitored by a PLC-based control system, providing both audible and visual notification of deviation from critical operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of steam pressure or come equipped with an integral, electrically heated steam generator.
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    K Number
    K041833
    Device Name
    CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
    Date Cleared
    2004-12-10

    (156 days)

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

    CONSOLIDATED MACHINE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Consolidated SSR and SR MC-Series Steam Sterilizers are intended for use by health care facilities. They are to be used to sterilize wrapped and unwrapped surgical instruments, linens, and liquids (liquids not intended for direct patient contact) by means of pressurized steam.
    Device Description
    The Consolidated SR and SSR Series Sterilizers are for general purpose gravity or vacuum steam sterilization of heat and moisture-stabile goods, surgical instruments, and supplies. All models utilize both gravity/downward air displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 16 cycles can be easily accessed and are password protected. All cycle phases are sequenced and monitored by the Mark V control system, providing both audible and visual notification of deviation from certain operating parameters. These sterilizers can either be supplied for connection to direct building steam supply of 50-80 PSI of pressure or come equipped with an integral, electrically heated steam generator.
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