Data / Medical devices / Canada / STERIS Canada ULC
STERIS Canada ULC: FDA-registered device maker in Quebec, Canada, 32 510(k) clearances
STERIS Canada ULC is registered with the FDA (registration 9680353) in Quebec, Canada. It lists 12 device types. The FDA files 32 510(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
- 9680353
- FEI number
- 3004097451
- Address
- 490 Boulevard Armand-Paris, Quebec, Canada, G1C 8A3
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- 1 Level General Purpose Rack (CM53) (QB-MF), 2 Level Manifold Rack (FD74800) (QB-MF), 2 Level Manifold Rack with Equal Level Space (FD79100) (QB-MF), 2 Level Manifold Rack with Equal Level Space - Large (FD81000) (QB-MF), 2-Level Instrument Rack for Reliance 333 (MB000015) (QB-CFE), 3 Level MIS Rack with Removable Upper Insert - Large (FD81600) (QB-MF), 3 Level Manifold Rack (FD009) (QB-MF), 3 Level Manifold Rack (FD74900) (QB-MF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning, For Endoscope | FEB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Accessories, Germicide, Cleaning, For Endoscopes | NZA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Complaint file establishment | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Endoscope Maintenance System | PUP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Exporter to the US | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilizer Automated Loading System | PEC | 2 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Chemical | MLR | 2 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Drying | JRJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Washer, Cleaner, Automated, Endoscope | NVE | 2 | Manufacturer | 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 |
| 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 |
| July 21, 2023 | K230560 | enspire 300 Series Automated Endoscope Reprocessor System | NZA | 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 30, 2022 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | NVE | Substantially Equivalent | Steris | 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 |
| August 25, 2022 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector | NVE | 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 |
| December 1, 2020 | K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | NVE | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 14, 2020 | K200989 | Reliance Endoscope Processing System | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 3, 2020 | K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | NVE | 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 21, 2019 | K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector | NVE | 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 |
| December 14, 2018 | K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | FEB | 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 |
| September 22, 2017 | K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | MED | 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 5, 2013 | K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | 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 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 |
| 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 Accessories, Germicide, Cleaning, For Endoscopes
- All makers of Sterilizer, Chemical
- All makers of Washer, Cleaner, Automated, Endoscope
- All makers of Sterilizer Automated Loading System
- All makers of Sterilizer, Steam
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.