Data / Medical devices / United States / STERIS Corporation
STERIS Corporation: FDA-registered device maker in Mentor, OH, United States, 50 510(k) clearances
STERIS Corporation is registered with the FDA (registration 3003950207) in Mentor, OH, United States. It lists 8 device types. The FDA files 50 510(k) clearances under its listings, the newest dated April 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003950207
- Address
- 6100 Heisley Rd, Mentor, OH, United States, 44060
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- October 12, 2020
- Registered through
- 2027
- Brand names listed
- 4085 General Surgical Table (MG-CFE), 4095 General Surgical Table (MG-MF), 4195 General Surgical Table (MG-MF), 5085 General Surgical Table (MG-CFE), 5085 Harmony Surgical Table (MG-CFE), 5095 General Surgical Table (MG-MF), 5195 General Surgical Table (MG-MF), 7080 General Surgical Table (MG-MF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning, For Endoscope | FEB | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Germicide, Cleaning, For Endoscopes | NZA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Endoscope Maintenance System | PUP | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Qualitative Cleaning Process Protein Indicator | SDC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Chemical | MLR | 2 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Ac-Powered | FQO | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 8, 2026 | K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 2, 2024 | K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | FEB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 12, 2024 | DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | SDC | Unknown | Steris | accessdata.fda.gov |
| October 20, 2023 | K233065 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | Steris | accessdata.fda.gov |
| October 3, 2023 | K232918 | enspire 300 Series Automated Endoscope Reprocessor | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 3, 2023 | K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 7, 2023 | K223476 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 21, 2023 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 30, 2023 | K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | FEB | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 28, 2023 | K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 28, 2022 | K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 9, 2022 | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | MLR | Substantially Equivalent | Steris | accessdata.fda.gov |
| March 10, 2022 | K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 7, 2021 | K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 12, 2021 | K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 28, 2021 | K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | NZA | Substantially Equivalent | Steris | accessdata.fda.gov |
| May 14, 2020 | K200989 | Reliance Endoscope Processing System | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 10, 2019 | K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 5, 2019 | K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 2, 2019 | K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape | JOJ | Substantially Equivalent | Intertape Polymer, Inc. | accessdata.fda.gov |
| May 9, 2019 | K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 5, 2019 | K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 22, 2019 | K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| January 31, 2019 | K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 4, 2018 | K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| March 2, 2018 | K173256 | System 1 endo Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172754 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 18, 2018 | K172319 | 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 | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 22, 2017 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 31, 2017 | K162413 | 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 | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 5, 2016 | K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 6, 2016 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 24, 2014 | K140498 | V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 16, 2013 | K131120 | AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 5, 2013 | K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 26, 2012 | K120632 | AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 21, 2012 | K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 1, 2011 | K112813 | AMSCO V-PRO | MLR | Substantially Equivalent | Steris Corp | accessdata.fda.gov |
| November 22, 2011 | K112760 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 2, 2011 | K111810 | AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 18, 2011 | K102394 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 12, 2011 | K102330 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 3, 2010 | K102244 | RELIANCE ENDOSCOPE PROCESSING SYSTEM | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 21, 2010 | K102462 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 2, 2010 | K101409 | SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 5, 2010 | K090036 | SYSTEM 1.5 STERILE PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 3, 2009 | K083097 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 4, 2007 | K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM | MLR | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 17, 2004 | K040049 | THE RELIANCE ENDOSCOPE PROCESSING SYSTEM | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilant, Medical Devices
- All makers of Sterilizer, Chemical
- All makers of Endoscope Maintenance System
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Accessories, Germicide, Cleaning, For Endoscopes
- All makers of Accessories, Cleaning, For Endoscope
Updated April 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.