FDA 510(k) Applications for Medical Device Product Code "JOJ"
(Indicator, Physical/Chemical Sterilization Process)

FDA 510(k) Number Applicant Device Name Decision Date
K193254 3M Company 3M Attest Steam Chemical Integrator 12/23/2019
K220942 3M Company 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) 06/24/2022
K020589 3M COMPANY 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE 04/22/2002
K093199 3M COMPANY 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK 12/04/2009
K183211 3M Company 3M Comply Hydrogen Peroxide Chemical Indicator 02/26/2019
K192937 3M Company 3M Comply Hydrogen Peroxide Chemical Indicator 11/16/2019
K170321 3M COMPANY 3M Comply Hydrogen Peroxide Chemical Indicator 1248 08/14/2017
K203458 3M Company 3M Comply Hydrogen Peroxide Chemical Indicator 1248 12/11/2020
K150622 3M Company 3M Comply Hydrogen Peroxide Chemical Indicator 1248 09/29/2015
K170563 3M Company 3M Comply Hydrogen Peroxide Indicator Tape 07/27/2017
K183209 3M Company 3M Comply Hydrogen Peroxide Indicator Tape 02/15/2019
K203285 3M Company 3M Comply Hydrogen Peroxide Indicator Tape 1228 12/10/2020
K150694 3M Company 3M Comply Hydrogen Peroxide Indicator Tape 1228 10/01/2015
K150477 3M COMPANY 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization 07/02/2015
K101528 3M COMPANY 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM 10/01/2010
K220564 3M Company 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 05/23/2022
K212081 3M Company 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 09/05/2021
K222152 3M Company 3MÖ AttestÖ Hydrogen Peroxide Indicator Tape 1228 09/23/2022
K191236 3M Company 3MÖ AttestÖ Steam Chemical Integrators 11/22/2019
K222508 3M Company 3MÖ ComplyÖ Hydrogen Peroxide Chemical Indicator 1248 11/01/2022
K192673 3M Company 3MÖ ComplyÖ Hydrogen Peroxide Indicator Tape 1228 10/28/2019
K101249 3M COMPANY STERIGAGE MODEL 1243RA, 1243RB, 1243RE 09/08/2010
K040742 ADVANCED STERILIZATION PRODUCTS MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE 04/02/2004
K111518 ADVANCED STERILIZATION PRODUCTS STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 10/03/2012
K103218 ADVANCED STERILIZATION PRODUCTS STERRAD CHEMICAL INDICATOR STRIP 04/01/2011
K022441 ADVANCED STERILIZATION PRODUCTS STERRAD SEALSURE CHEMICAL INDICATOR TAPE 10/08/2002
K103219 ADVANCED STERILIZATION PRODUCTS STERRAD SEALSURE CHEMICAL INDICATOR TAPE 04/01/2011
K111519 ADVANCED STERILIZATION PRODUCTS STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 10/03/2012
K061738 ALBERT BROWNE LTD. ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD 08/25/2006
K060103 ALBERT BROWNE LTD. ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS 03/07/2006
K991709 ALBERT BROWNE LTD. BROWNE CIDEX OPA INDICATOR 10/08/1999
K981054 ALBERT BROWNE LTD. BROWNE GA INDICATOR FOR CIDEX PRODUCTS 12/07/1998
K012335 ALBERT BROWNE LTD. BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS 10/01/2001
K991418 ALBERT BROWNE LTD. BROWNE MVI ETHYLENE OXIDE INDICATOR 06/10/1999
K971369 ALBERT BROWNE LTD. BROWNE MVI STEAM INDICATOR 01/29/1998
K992767 ALBERT BROWNE LTD. BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR 01/10/2000
K984616 ALBERT BROWNE LTD. BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION 02/04/1999
K984613 ALBERT BROWNE LTD. BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION 02/04/1999
K002741 ALBERT BROWNE LTD. BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK 07/03/2002
K032801 ALBERT BROWNE LTD. MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR 10/17/2003
K063285 ALBERT BROWNE LTD. RELIANCE CI PROCESS INDICATOR 01/12/2007
K060066 ALBERT BROWNE LTD. VERIFY 3-10 MIN FLASH INTEGRATOR 03/24/2006
K053479 ALBERT BROWNE LTD. VERIFY DRY HEAT LABEL 07/18/2006
K051101 ALBERT BROWNE LTD. VERIFY FLASH INTEGRATOR 12/06/2005
K971888 ALDEN SCIENTIFIC, INC. GLUTATECT 01/09/1998
K200334 Andersen Sterilizers, Inc. AN1036 Dosimeter 11/12/2020
K150645 ANDERSEN STERILIZERS, INC. AN1087 Dosimeter 11/19/2015
K150644 ANDERSEN STERILIZERS, INC. AN85/AN86 EO Indicators 11/18/2015
K170439 Andersen Sterilizers, Inc. AN87 Dosimeter 11/01/2017
K170426 Andersen Sterilizers,Inc. AN85/AN86 EO Indicators 10/30/2017
K970918 BOARD OF DIRECTORS, ALBERT BROWNE LTD. BROWNE STEAM INDICATOR 06/24/1997
K971971 BOARD OF DIRECTORS, ALBERT BROWNE LTD. BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK 07/10/1998
K161024 Canadian Technical Tape, Ltd. Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape 06/28/2016
K140940 CANADIAN TECHNICAL TAPE, LTD. PROCESS INDICATOR TAPE FOR STEAM STERILIZATION 10/27/2014
K982151 CASE MEDICAL, INC. STERITITE PROCESS INDICATOR ACCESSORIES 02/09/1999
K960089 COTTRELL, LTD. PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR 04/04/1996
K143520 CROSSTEX SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) 06/09/2015
K133204 CROSSTEX INTERNATIONAL AIRVIEW MINI OWIE DICK TEST PACK 05/05/2014
K140566 CROSSTEX INTERNATIONAL SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE 11/24/2014
K200096 Crosstex International, Inc. (A Cantel Medical Company) Crosstex VH2O2 Chemical Indicators 07/15/2021
K100891 DANA PRODUCTS, INC. DANA EMULATING INDICATOR 01/13/2011
K130135 DANA PRODUCTS, INC. DANA REUSABLE BI TEST PACK 11/25/2013
K120592 DANA PRODUCTS, INC. DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS 02/27/2013
K102761 DANA PRODUCTS, INC. DANA REUSABLE TEST PACK FOR STEAM STERILIZATION 12/20/2010
K110253 DANA PRODUCTS, INC. REUSABLE TEST PACK FOR DANA EMULATING INDICATORS 04/29/2011
K012195 DANA PRODUCTS, INC. STEAM STERILIZATION INTERGRATOR 05/07/2002
K031647 GETINGE USA, INC BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR 07/29/2003
K070419 HACH COMPANY OPACIDEN OPA REAGENT STRIPS 08/31/2007
K110369 INDILAB, INC. INDISTRIP GREEN 05/06/2011
K191741 Intertape Polymer Inc. Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape 08/02/2019
K181788 Kem Medical Products Corp. Lead-free Chemical Indicators for Steam Sterilization 03/01/2019
K974415 KIMBERLY-CLARK CORP. KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP 07/10/1998
K152394 MEDIVATORS INC. Rapicide PA High-Level Disinfectant Test Strips 03/11/2016
K013228 MINNESOTA MINING AND MFG. CO. 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR 01/18/2002
K000355 MINNESOTA MINING AND MFG. CO. 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR 08/23/2000
K103126 NANOSONICS LIMITED TROPHON CHEMICAL INDICATOR 03/03/2011
K101580 NEV'S INK, INC NEV'S INK AUTOCLAVE TAPES 07/01/2010
K983451 NORTH AMERICAN SCIENCE ASSOC., INC. CHALLENGE TEST PACK 04/23/1999
K132291 NORTH AMERICAN SCIENCE ASSOC., INC. NAMSA CHEMICAL PROCESS 05/20/2014
K212592 Propper Manufacturing Co., Inc. Gas-Chex Indicator 01/20/2022
K222137 Propper Manufacturing Co., Inc. OK Plus Indicator 12/05/2022
K210553 Propper Manufacturing Co., Inc. Steam-Dot Process Indicator 05/19/2021
K210866 Propper Manufacturing Co., Inc. Steri-Dot Process Indicator 06/21/2021
K102894 PROPPER MFG. CO., INC. CLASSIX CHEMICAL STERILIZATION INDICATOR 05/25/2011
K961156 PROPPER MFG. CO., INC. ONCE-A-DAY BOWIE AND DICK TEST PACK. 04/01/1997
K082620 PROPPER MFG. CO., INC. ONCE-A-DAY VERTOS TEST PACK 07/08/2009
K991276 PROPPER MFG. CO., INC. PASS/FAIL CHALLENGE PACK 07/12/1999
K973585 PROPPER MFG. CO., INC. PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR 11/06/1998
K031152 PROPPER MFG. CO., INC. PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) 08/17/2004
K111453 PROPPER MFG. CO., INC. STEAM DOT BLU PROCESS INDICATOR 04/05/2012
K952995 PYMAH CORP. ATI ETHYLENE OXIDE STERILIZATION INDICATOR 02/22/1996
K062651 RAVEN BIOLOGICAL LABORATORIES, INC. PROCHEM EXT CHEMICAL INTEGRATOR 03/15/2007
K080307 RAVEN LABORATORIES PROCHEM INDICATOR TAPE 05/01/2008
K992341 SERIM RESEARCH CORP. CIDEX OPA SOLUTION TEST STRIP 11/23/1999
K120652 SERIM RESEARCH CORP. RAPICIDE OPA-28 TEST STRIP 10/12/2012
K092346 SERIM RESEARCH CORP. SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 01/07/2010
K083295 SERIM RESEARCH CORP. SERIM DISINTEK GTA 2.1%, MODEL: 5164 03/16/2009
K082352 SERIM RESEARCH CORP. SERIM DISINTEK OPA TEST STRIP 09/25/2008
K081370 SERIM RESEARCH CORP. SERIM DISINTEK OPA TEST STRIP 07/11/2008
K052388 SERIM RESEARCH CORP. SERIM PERACETIC ACID CHEMICAL INDICATOR 12/01/2005
K972035 SERIM RESEARCH CORP. SPOROX TEST STRIPS 08/29/1997
K192445 Serim Research Corporation QwikCheck Chemical Indicators 04/02/2020
K202565 Serim Research Corporation WAVICIDE-OPA MEC Indicator 12/02/2020
K130211 SPS MEDICAL SUPPLY CORP. AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS 07/05/2013
K041017 SPS MEDICAL SUPPLY CORP. SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK 06/25/2004
K102363 SPS MEDICAL SUPPLY CORP. SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004 01/27/2011
K030680 SPS MEDICAL SUPPLY CORP. SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR 05/09/2003
K090650 SPS MEDICAL SUPPLY CORP. SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS 10/09/2009
K063799 SPS MEDICAL SUPPLY CORP. STEAMPLUS STEAM INTEGRATOR 01/05/2007
K020409 SPS MEDICAL SUPPLY CORP. STEAMPLUS STERILIZATION TEST 07/18/2002
K110152 SPSMEDICAL SUPPLY CORP. SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS 04/15/2011
K191999 Sterilucent, Inc. Sterilucent VH2O2 Chemical Indicators 10/21/2019
K231488 STERIS CelerityÖ HP Chemical Indicator; CelerityÖ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape 08/07/2023
K213412 STERIS Corparation VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM 01/21/2022
K120435 STERIS Corporation BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR 06/04/2012
K081427 STERIS Corporation BROWNE OPA TEST STRIP 06/11/2008
K080750 STERIS Corporation BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR 05/12/2008
K192020 STERIS Corporation Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label 09/05/2019
K182724 STERIS Corporation CelerityTM 10 STEAM Chemical Indicator 12/10/2018
K172472 STERIS Corporation Micro-MEC 1.8% Glutaraldehyde Monitor Strip 11/17/2017
K230558 STERIS Corporation Revital-Ox PAA High Level Disinfectant Chemical Indicator 07/17/2023
K143333 STERIS Corporation Revital-Ox RESERT Solution Test Strip 04/14/2015
K081600 STERIS Corporation STERIS RESERT XL TEST STRIP 08/22/2008
K112256 STERIS Corporation STERIS STEAM PI 01/11/2012
K102217 STERIS Corporation SYSTEM 1E CHEMICAL INDICATOR 11/22/2010
K043482 STERIS Corporation THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 12/21/2004
K103053 STERIS Corporation VERIFY 270FP CHALLENGE PACK 03/10/2011
K071895 STERIS Corporation VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR 11/14/2007
K083643 STERIS Corporation VERIFY 275F GRAVITY INDICATORS 08/07/2009
K103331 STERIS Corporation VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES 09/01/2011
K073683 STERIS Corporation VERIFY CHALLENGE PACKS - VERSION 2 01/25/2008
K070895 STERIS Corporation VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK 09/05/2007
K173428 STERIS Corporation VERIFY Chemical Indicator for S40 Sterilant 03/02/2018
K102296 STERIS Corporation VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) 02/09/2011
K140515 STERIS Corporation VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL 07/17/2014
K130160 STERIS Corporation VERIFY PROCESS INDICATOR FOR RELIANCE EPS 08/16/2013
K162758 STERIS Corporation VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack 03/21/2017
K070461 STERIS Corporation VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 07/17/2007
K152630 STERIS CORPORATION VERIFY STEAM Integrating Indicator 05/12/2016
K162631 STERIS CORPORATION VERIFY STEAM Integrating Indicator - Short 01/27/2017
K091174 STERIS Corporation VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL 10/27/2009
K072510 STERIS Corporation VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 12/11/2007
K183293 STERIS Corporation VERIFY VH202 Indicator Tape 01/04/2019
K160485 STERIS CORPORATION VERIFY VH2O2 Indicator Tape 06/01/2016
K172753 Steris Corporation VERIFY VH2O2 Indicator Tape 02/09/2018
K172746 STERIS Corporation VERIFY« HPU Chemical Indicator and VERIFY« Vaporized VH2O2 Process Indicator Adhesive Label 02/09/2018
K183295 Steris Corporations Celerity HP Chemical Indicator (CI) 01/04/2019
K200252 SteriTec Products MFG Co Inc Getinge Assured MI Steam Migrating Integrator 05/21/2020
K952244 STERITEC PRODUCTS MFG. CO., INC. CROSS-CHECKS EO GAS STERILIZATION MONITOR 08/05/1996
K972300 STERITEC PRODUCTS MFG. CO., INC. CROSS-CHECKS P 03/25/1998
K072408 STERITEC PRODUCTS MFG. CO., INC. EMU-GRAPH EMULATOR, MODEL CI 131 04/30/2008
K103000 STERITEC PRODUCTS MFG. CO., INC. SMART READ BIOLOGICAL TEST PACK 02/11/2011
K000502 STERITEC PRODUCTS MFG. CO., INC. STEAM/EO RECORD CARD, MODEL CI 121 03/14/2000
K982188 STERITEC PRODUCTS MFG. CO., INC. STERI-PAK BOWIE DICK TEST PACK 11/20/1998
K990246 STERITEC PRODUCTS MFG. CO., INC. STERI-PAK LF BOWIE-DICK TEST PACK 06/10/1999
K955426 STERITEC PRODUCTS MFG. CO., INC. STERITEC CROSS-CHECKS 03/12/1996
K982547 STERITEC PRODUCTS MFG. CO., INC. STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR 10/08/1998
K965212 STERITEC PRODUCTS MFG. CO., INC. STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM 04/23/1998
K953122 STERITEC PRODUCTS MFG. CO., INC. STERITEC DRY HEAT INDICATOR LABEL 04/02/1997
K132372 STERITEC PRODUCTS MFG. CO., INC. STERITEC GREEN CARD PACK BOWIE-DICK TEST 11/26/2013
K122945 STERITEC PRODUCTS MFG. CO., INC. STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 04/30/2013
K960441 STERITEC PRODUCTS MFG. CO., INC. STERITEC INTEGRAPH MODEL CI-101 05/08/1997
K122555 STERITEC PRODUCTS MFG. CO., INC. STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE 12/12/2012
K024293 STERITEC PRODUCTS, INC. BOWIE-DICK MINI PAK, MODEL BD 115 08/11/2003
K010534 STERITEC PRODUCTS, INC. CROSS-CHECKS DUAL, MODEL CI 125 08/06/2001
K003533 STERITEC PRODUCTS, INC. CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L 02/07/2001
K083650 STERITEC PRODUCTS, INC. EMU-GRAPH 4 EMULATOR, MODEL CI 144 03/05/2009
K002861 STERITEC PRODUCTS, INC. EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 11/29/2000
K080136 STERITEC PRODUCTS, INC. INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 08/15/2008
K012732 STERITEC PRODUCTS, INC. INTEGRAPH FLASH, MODEL CI 110 03/04/2002
K003002 STERITEC PRODUCTS, INC. STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 12/08/2000
K001649 STERITEC PRODUCTS, INC. STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 06/23/2000
K052516 STERITEC PRODUCTS, INC. STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 10/03/2005
K040901 STERITEC PRODUCTS, INC. STERITEC EMU-GRAPH, MODEL NO. CI 131/US 09/09/2004
K001444 STERITEC PRODUCTS, INC. STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 05/15/2000
K020612 SULTAN CHEMISTS, INC. SULTAN SPOROX TEST VIAL, MODEL 75195 05/07/2002
K021161 TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC TSO3 OZONE CHEMICAL INDICATOR 08/27/2003
K200272 Terragene SA Terragene Chemdye 06/30/2020
K220778 True Indicating LLC Chemical Indicator for Steam 12/02/2022
K141698 TSO3 INC. STERIZONE CHEMICAL INDICATOR 12/17/2014
K143629 U&U MEDICAL TECHNOLOGY CO., LTD U&U Bowie-Dick Test Pack 05/19/2015
K171823 U&U Medical Technology Co., Ltd U&U Indicator tape and strip 02/22/2018


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