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

    STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER

    K Number: K140464 · Decision Oct 31, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    249

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
    K Number
    K140464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilucent, Inc.
    Date Received
    February 24, 2014
    Decision Date
    October 31, 2014
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MLR), ordered by most recent decision date.

    STERRAD 100NX Sterilization System with ALLClear Technology (10104)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LOWTEM Crystal 120

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SteroScope® Sterilization Technology System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    V-PRO maX 2 Low Temperature Sterilization System

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Sterilucent, Inc.

    K Number Device Name
    K192001 Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
    K191999 Sterilucent VH2O2 Chemical Indicators
    K190005 Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
    K142109 STERILUCENT STERILIZATION CONTAINER SYSTEM
    K141238 STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
    K141312 STERILUCENT PROCESS CHALLENGE DEVICE