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

    Revital-Ox PAA High Level Disinfectant Chemical Indicator

    K Number: K230558 · Decision Jul 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    204
    Review Days
    139

    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
    Revital-Ox PAA High Level Disinfectant Chemical Indicator
    K Number
    K230558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STERIS Corporation
    Date Received
    February 28, 2023
    Decision Date
    July 17, 2023
    Product Code
    JOJ
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

    Similar 510(k) Clearances

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

    LF Process Indicator Tape for Steam Sterilization

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISINTEK™ PA Test Strips

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERIFY STEAM Integrating Indicator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Green Card Bowie-Dick Test (BD115)

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

    Other Clearances by STERIS Corporation

    K Number Device Name
    K260766 Celerity 5 HP Biological Indicator (LCB052)
    K251666 SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
    K252680 Celerity™ 20 HP Biological Indicator
    K251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
    K243876 VERIFY STEAM Integrating Indicator
    K250842 PADLOCK CLIP EFTR Kit (00713229)
    K250061 Celerity Incubator
    K250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
    K243475 Chemical Indicator for enspire CLCSPS (LCC015)
    K243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
    Search all 204 clearances from STERIS Corporation →