FDA 510(k) Applications Submitted by STERIS Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K170070 01/09/2017 VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles STERIS Corporation
K160485 02/22/2016 VERIFY VH2O2 Indicator Tape STERIS CORPORATION
K160908 04/01/2016 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS CORPORATION
K160912 04/01/2016 Sterilization Tray STERIS CORPORATION
K171504 05/23/2017 VERIFY Assert VH2O2 Self-Contained Biological Indicator STERIS Corporation
K171587 05/31/2017 VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator Steris Corporation
K181442 06/01/2018 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation
K181429 06/01/2018 CELERITY 20 HP Biological Indicator STERIS Corporation
K172474 08/15/2017 Celerity 20 HP Biological Indicator Steris Corporation
K162701 09/28/2016 VERIFY Assert Self-Contained Biological Indicator STERIS CORPORATION
K162758 09/30/2016 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack STERIS Corporation
K173481 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation
K173485 11/13/2017 Amsco Evolution Medium Steam Sterilizer STERIS Corporation
K173488 11/13/2017 CELERITY 20 HP Challenge Pack STERIS Corporation
K173490 11/13/2017 Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation
K173493 11/13/2017 Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 STERIS Corporation
K143333 11/20/2014 Revital-Ox RESERT Solution Test Strip STERIS Corporation
K173626 11/24/2017 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation
K173629 11/24/2017 CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation
K173634 11/24/2017 CELERITY 20 Steam Biological Indicator STERIS Corporation
K183293 11/27/2018 VERIFY VH202 Indicator Tape STERIS Corporation
K183294 11/27/2018 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack STERIS Corporation
K173670 11/30/2017 CELERITY 20 Steam Incubator STERIS Corporation
K163587 12/20/2016 VERIFY Incubator for Assert Self Contained Biological Indicators STERIS Corporation
K120435 02/13/2012 BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR STERIS Corporation
K160433 02/16/2016 V-PRO« 1 Plus and V-PRO« maX Low Temperature STERIS CORPORATION
K140498 02/27/2014 V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K140499 02/27/2014 VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS Corporation
K140515 02/28/2014 VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL STERIS Corporation
K120632 03/01/2012 AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K131120 04/22/2013 AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K172319 08/01/2017 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation
K162413 08/29/2016 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation
K172746 09/12/2017 VERIFY« HPU Chemical Indicator and VERIFY« Vaporized VH2O2 Process Indicator Adhesive Label STERIS Corporation
K172753 09/12/2017 VERIFY VH2O2 Indicator Tape Steris Corporation
K172754 09/12/2017 V-PRO maX 2 Low Temperature Sterilization System Steris Corporation
K152630 09/15/2015 VERIFY STEAM Integrating Indicator STERIS CORPORATION
K182568 09/18/2018 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation
K140708 03/21/2014 VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR STERIS Corporation
K182724 09/28/2018 CelerityTM 10 STEAM Chemical Indicator STERIS Corporation
K162945 10/21/2016 VERIFY ASSERT STEAM Process Challenge Device STERIS Corporation
K181865 07/12/2018 Acu-sInQ Complete Endoscope Cleaning Aid System STERIS Corporation
K172472 08/15/2017 Micro-MEC 1.8% Glutaraldehyde Monitor Strip STERIS Corporation
K172752 09/12/2017 CELERITY 20 HP Biological Indicator Steris Corporation
K173633 11/24/2017 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag Steris Corporation
K183297 11/27/2018 Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation
K183301 11/27/2018 PRO-LITE Sterilization Tray STERIS Corporation
K070461 02/16/2007 VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 STERIS Corporation
K080750 03/17/2008 BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR STERIS Corporation
K070895 03/30/2007 VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK STERIS Corporation
K081600 06/06/2008 STERIS RESERT XL TEST STRIP STERIS Corporation
K071895 07/09/2007 VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR STERIS Corporation
K072072 07/30/2007 HARMONY LED-1 SURGICAL LIGHTING SYSTEM STERIS Corporation
K073683 12/28/2007 VERIFY CHALLENGE PACKS - VERSION 2 STERIS Corporation
K091022 04/09/2009 MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT STERIS Corporation
K090514 02/26/2009 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES STERIS Corporation
K071087 04/17/2007 VIS-U-ALL II HEAT-SEAL POUCH AND TUBING STERIS Corporation
K083097 10/17/2008 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K073244 11/19/2007 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES STERIS Corporation
K073618 12/26/2007 VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK STERIS Corporation
K080420 02/15/2008 RESERT XL HLD HIGH LEVEL DISINFECTANT STERIS Corporation
K090136 01/21/2009 STERIS CMAX XLT SURGICAL TABLE STERIS Corporation
K072510 09/06/2007 VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 STERIS Corporation
K090371 02/13/2009 VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM STERIS Corporation
K083643 12/09/2008 VERIFY 275F GRAVITY INDICATORS STERIS Corporation
K083665 12/10/2008 VERIFY SCBI 275F 3-10 STERIS Corporation
K020747 03/07/2002 AMSCO CENTURY MEDIUM STERILIZER 26 X 26 STERIS Corporation
K030789 03/12/2003 AMSCO CENTURY STEAM STERILIZER STERIS Corporation
K971390 04/14/1997 QUANTUM 3080SP SURGICAL TABLE STERIS Corporation
K130160 01/23/2013 VERIFY PROCESS INDICATOR FOR RELIANCE EPS STERIS Corporation
K131078 04/17/2013 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation
K173256 10/10/2017 System 1 endo Liquid Chemical Sterilant Processing System Steris Corporation
K123768 12/07/2012 RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation
K180553 03/01/2018 VERIFY Spore Test Strip for S40 Sterilant Steris Corporation
K182827 10/05/2018 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 STERIS Corporation
K173428 11/02/2017 VERIFY Chemical Indicator for S40 Sterilant STERIS Corporation
K043482 12/17/2004 THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 STERIS Corporation
K971307 04/08/1997 AMSCO SURGICAL TABLE STERIS Corporation
K980369 01/30/1998 T.B.Q. RTU STERIS Corporation
K983947 11/05/1998 AMERSE 2 STERIS Corporation
K040049 01/12/2004 THE RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation
K070765 03/20/2007 VIS-U-ALL II SELF SEAL POUCH STERIS Corporation
K070769 03/20/2007 VHP 136 TRAY STERIS Corporation
K062297 08/07/2006 VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K090036 01/06/2009 SYSTEM 1.5 STERILE PROCESSING SYSTEM STERIS Corporation
K980014 01/02/1998 THE SYSTEM 2S STEAM STERILIZER STERIS Corporation
K000077 01/11/2000 STERIS AMSCO MILLENNIUM STEAM STERILIZER STERIS Corporation
K010865 03/22/2001 AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY STERIS Corporation
K982332 07/02/1998 STERIS TEN SIXTEEN STEAM STERILIZER STERIS Corporation
K983068 09/02/1998 RELIANCE FAMILY OF WASHER-DISINFECTORS STERIS Corporation
K003577 11/20/2000 STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT STERIS Corporation
K100049 01/08/2010 SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT STERIS CORPORATION
K100395 02/16/2010 HARMONY VLED SURGICAL LIGHTNING SYSTEM STERIS Corporation
K110453 02/16/2011 RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation
K101409 05/19/2010 SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM STERIS Corporation
K081427 05/21/2008 BROWNE OPA TEST STRIP STERIS Corporation
K111810 06/27/2011 AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS STERIS Corporation
DEN110002 08/01/2011 SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT STERIS Corporation
K112256 08/05/2011 STERIS STEAM PI STERIS Corporation
K102296 08/13/2010 VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) STERIS Corporation
K102394 08/23/2010 AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K102462 08/27/2010 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation
K102469 08/30/2010 VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR STERIS CORPORATION
DEN110006 09/06/2011 VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR STERIS Corporation
K112760 09/22/2011 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K103053 10/15/2010 VERIFY 270FP CHALLENGE PACK STERIS Corporation
K113520 11/29/2011 SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation
K110769 03/18/2011 AMSCO WARMING CABINET STERIS Corporation
K091136 04/20/2009 AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 STERIS Corporation
K091174 04/22/2009 VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL STERIS Corporation
K111223 05/02/2011 AMSCO CHIMERON SMALL STEAM STERILIZER STERIS Corporation
K091731 06/11/2009 AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation
K111870 07/01/2011 AMSCO WARMING CABINET STERIS Corporation
K112055 07/19/2011 AMSCO CHIMERON MEDIUM STEAM STERILIZER STERIS Corporation
K102217 08/06/2010 SYSTEM 1E CHEMICAL INDICATOR STERIS Corporation
K102244 08/09/2010 RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation
K092490 08/13/2009 AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 STERIS Corporation
K102330 08/17/2010 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation
K082435 08/22/2008 AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS Corporation
K112403 08/22/2011 AMSCO CHIMERON MEDIUM STEAM STERLILZER STERIS Corporation
K092745 09/08/2009 VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU STERIS Corporation
K092823 09/14/2009 AMSCO WARMING CABINET STERIS Corporation
K092906 09/21/2009 VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION STERIS Corporation
K103226 11/01/2010 STERILIZATION MATS STERIS Corporation
K103331 11/12/2010 VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS Corporation
K991167 04/07/1999 STERIS SMOKE EVACUATION SYSTEM STERIS Corporation
K041924 07/16/2004 HAUSTED POWERTRAN SERIES STRETCHER STERIS Corporation
K013242 09/28/2001 AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM STERIS Corporation
K140494 02/27/2014 V-PRO STERILIZATION TRAY/ STERILIZATION MAT STERIS Corporation
K140487 02/27/2014 VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING STERIS Corporation
K180689 03/15/2018 Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device STERIS Corporation
K181686 06/26/2018 CELERITY 20 Steam Biological Indicator STERIS Corporation
K170956 03/31/2017 SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation
K161683 06/17/2016 SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS CORPORATION
K172749 09/12/2017 Vis-U-All Low Temperature Sterilization Pouch/Tubing Steris Corporation
K172755 09/12/2017 PRO-LITE Sterilization Trays Steris Corporation
K162631 09/21/2016 VERIFY STEAM Integrating Indicator - Short STERIS CORPORATION


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