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510(k) Data Aggregation

    K Number
    K111453
    Device Name
    STEAM DOT BLU PROCESS INDICATOR
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    2012-04-05

    (316 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Steam Dot Blu ° Process Indicator is a chemical sterilization indicator intended to be used by a health care provider with sterilization wraps, containers, cassettes, pouches or other packaging materials to distinguish between processed and unprocessed units. The indicator changes color from blue to pink when exposed to steam sterilization conditions at 121°C in gravity displacement and 132°C, 134°C and 135°C in pre-vacuum cycles. The performance of the Steam Dot-Blu® Process Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for process (Class 1) indicators. No lead or heavy metals or their compounds are added in the production of the indicator.
    Device Description
    Steam Dou Blu® Process Indicator is a single use chemical sterilization indicator for steam sterilizers. It complies with the requirements established in the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003 and "ANSI/AAMVISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1: General requirements" standard for process indicators. Steam Dot Blu® Process Indicator is designed to be used in 121°C gravity and in 132°C, 134°C and 135°C pre-vacuum steam sterilization cycles. During sterilization cycles the indicator change color from blue to pink. The color change after processing is stable. No lead or heavy metals or their compounds are added in the production of the indicator.
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    K Number
    K102894
    Device Name
    CLASSIX CHEMICAL STERILIZATION INDICATOR
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    2011-05-25

    (237 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emu-Chex™ Sterilization Indicator is an emulating indicator intended to be used by a health care provider to monitor steam sterilization processes. Ennu-Chex" Sterilization Indicator comes in three varieties; for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in pro-vacuum steam sterilization processes operating at 132°C for 4 minutes and 135°C for 3 minutes. The Emu-Chex™ Sterilization Indicators can be placed together with items to be steam sterifized. The indicator changes color from blue-green to brown when the sterilization cycle is complete. The performance of the Enni-Chex" Sterilization Indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2005 for emulating indicators.
    Device Description
    The Emu-Chex™ Sterilization Indicator is a chemical sterilization indicator for steam sterilizers that complies with ANSI/AAMI/ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part 1 : General requirements, emulating indicators. The variety of Emu-Chex sterilization indicators includes those for use in a gravity steam sterilization process operating at 121°C for 20 minutes, for use in prevacuum steam sterilization process operating at 132° C for 4 minutes and 135° C for 3 minutes. No lead or heavy metals or their compounds are added in the production of the indicator.
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    K Number
    K082620
    Device Name
    ONCE-A-DAY VERTOS TEST PACK
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    2009-07-08

    (302 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.
    Device Description
    The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.
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    K Number
    K031152
    Device Name
    PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    2004-08-17

    (494 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propper Vapor Line PCD is indicated for use in routine challenge testing steam sterilizers in pre-vacuum cycles operating at 273.2°F/134°C. The PROPPER VAPOR LINE PCD is indicated for use as a routine process challenge test for steam sterilizers in pre-vacuum cycles at 273.2°F/134°C.
    Device Description
    Propper Vapor Line PCD is a process challenge test device for use in pre-vacuum steam sterilization processes at 273.2°F/134°C. It consists of a capsule with a removable cap and sample holder to permit the positioning and removal of the Propper Vapor Line Integrator. One end of the capsule is connected to a lumen. During the sterilization cycle, the open end of the lumen permits residual air to exit and steam to enter the capsule The integrator display will indicate whether or not sterilization conditions were attained inside the metal capsule.
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    K Number
    K991618
    Device Name
    BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    2001-01-24

    (624 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
    Device Description
    The Propper BI-O.K. self contained steam biological indicator consists of a plastic vial and cap which contain a paper strip impregnated with a known number of B. stearothermophilus spores and a sterile sealed glass ampule containing a modified Soybean Casein Digest Medium with pH indicator. Following exposure in a steam sterilizer, the glass ampule is crushed by squeezing the sides of the plastic vial , thus bringing the medium into contact with the spores. The vial is incubated at 56± 2℃ for at least 24 hours. If any of the spores survived the sterilization process, they will grow and produce acid. This will cause a drop in pH of the medium and change the indicator from red to yellow.
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    K Number
    K991276
    Device Name
    PASS/FAIL CHALLENGE PACK
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    1999-07-12

    (89 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
    Device Description
    The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BT- O.K. M steam sterilization test pack.
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    K Number
    K973585
    Device Name
    PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    1998-11-06

    (410 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Propper EO LINE™ is indicated to be an ethylene oxide sterilization integrator for use in EO sterilizers with 10% ethylene oxide : 90% HCFC gas mixtures. Its function is to monitor the exposure conditions for EO sterilization and to ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met.
    Device Description
    Propper EO LINE™ Ethylene Oxide Sterilization Integrator
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    K Number
    K972747
    Device Name
    BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    1998-01-09

    (170 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prior BI O.K." EO Gas Biological Test-Pak is intended for use as a disposable device for the biological monitoring of ethylene oxide sterilizers in health care facilities. Its construction closely duplicates that described for such testing by AAMI/ANSI ST41-1992. The Propper BI-O.K. Gas Biological Test Pack is indicated for use as an aid or adjunct for use in biological monitoring of ethylene oxide sterilizers only. Its performance was verified versus the standard AAMI pack under the conditions of 600 mg/L ethylene oxide, 60% RH, 54.4 C in a Joslyn BIER vessel using a 10% ethylene oxide, 90% HCFC gas mixture.
    Device Description
    The BI-O.K. EO Gas Biological Test-Pak consists of a BI-O.K. EO Gas Biological Indicator placed inside a plastic syringe. The syringe along with a Record Card and absorbent towel are enclosed in a paper/plastic peel pouch suitable for use in ethylene oxide sterilizers.
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    K Number
    K961156
    Device Name
    ONCE-A-DAY BOWIE AND DICK TEST PACK.
    Manufacturer
    PROPPER MFG. CO., INC.
    Date Cleared
    1997-04-01

    (375 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPPER MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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