BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERRAD 100NX Sterilization System with ALLClear Technology (10104)

    K Number: K252843 · Decision Apr 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    219

    Basic Information

    Device Name
    STERRAD 100NX Sterilization System with ALLClear Technology (10104)
    K Number
    K252843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Sterilization Products, Inc.
    Date Received
    September 8, 2025
    Decision Date
    April 15, 2026
    Product Code
    MLR
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLR Sterilizer, Chemical

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    Other Clearances by Advanced Sterilization Products, Inc.

    K Number Device Name
    K250802 STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
    K234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)
    K220404 STERRAD NX with ALLClear Technology
    K212174 STERRAD 100NX Sterilizer with ALLClear Technology