Data / Medical devices / United States / STERIS Corporation
STERIS Corporation: FDA-registered device maker in Mentor, OH, United States, 61 510(k) clearances
STERIS Corporation is registered with the FDA (registration 3000251274) in Mentor, OH, United States. It lists 9 device types. The FDA files 61 510(k) clearances under its listings, the newest dated October 2, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3000251274
- Address
- 6515 Hopkins RD., Mentor, OH, United States, 44060
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- AMSCO Drying Cabinets (QB-RR), Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD), Celerity 20 STEAM Biological Indicator (LCB048), Celerity 20 STEAM Biological Indicator (LCB048) (PC-MF), Celerity 20 STEAM Biological Indicator (LCB063) (PC-UMXD), Celerity 20 STEAM Process Challenge Device for Dynamic Air Removal Cycles (LCB064, LCB065) (PC-UMXD), Celerity HP Chemical Indicator (PCC074) (LC-CFE), Celerity HP Chemical Indicator (PCC075) (LC-MF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Accessories, Cleaning, For Endoscope | FEB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Germicide, Cleaning, For Endoscopes | NZA | 2 | Manufacturer | accessdata.fda.gov |
| Biological Sterilization Process Indicator With Recombinant-Dna Plasmid | OWP | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope Maintenance System | PUP | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 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 |
|---|---|---|---|---|---|---|
| October 2, 2026 | K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | FEB | Substantially Equivalent | Steris | accessdata.fda.gov |
| 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 |
| April 25, 2025 | K243876 | VERIFY STEAM Integrating Indicator | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 6, 2025 | K250061 | Celerity Incubator | FRC | 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 |
| August 20, 2024 | K242189 | CELERITY HP Indicator Tape (PCC077) | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| April 10, 2024 | K240760 | CELERITY HP Indicator Tape | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| December 15, 2023 | K233681 | ConFirm 20 Minute Incubator | FRC | 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 |
| August 7, 2023 | K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | JOJ | Substantially Equivalent | Steris | 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 |
| June 15, 2023 | K223715 | Celerity Incubator | FRC | 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 |
| July 21, 2022 | K213881 | Celerity Incubator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 21, 2022 | K213412 | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM | JOJ | Substantially Equivalent | Steris Corparation | 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 |
| 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 |
| May 14, 2019 | K190297 | Celerity HP Incubator | FRC | 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 4, 2019 | K183293 | VERIFY VH202 Indicator Tape | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 20, 2018 | K182931 | 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 | FRC | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| July 24, 2018 | K181686 | CELERITY 20 Steam Biological Indicator | FRC | 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 28, 2018 | K173633 | 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 | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 12, 2018 | K173670 | CELERITY 20 Steam Incubator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 12, 2018 | K173634 | CELERITY 20 Steam Biological Indicator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172753 | VERIFY VH2O2 Indicator Tape | JOJ | 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 22, 2017 | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 24, 2017 | K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | OWP | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 21, 2017 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 27, 2017 | K162631 | VERIFY STEAM Integrating Indicator - Short | JOJ | 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 |
| June 28, 2016 | K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | JOJ | Substantially Equivalent | Canadian Technical Tape, Ltd. | accessdata.fda.gov |
| June 1, 2016 | K160485 | VERIFY VH2O2 Indicator Tape | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 12, 2016 | K152630 | VERIFY STEAM Integrating Indicator | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 11, 2014 | K133267 | DANA REUSABLE TEST PACK | FRC | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| November 25, 2013 | K130135 | DANA REUSABLE BI TEST PACK | JOJ | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| July 5, 2013 | K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 27, 2013 | K120592 | DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS | JOJ | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| February 21, 2012 | K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 29, 2011 | K110253 | REUSABLE TEST PACK FOR DANA EMULATING INDICATORS | JOJ | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| March 10, 2011 | K103053 | VERIFY 270FP CHALLENGE PACK | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 16, 2011 | K103321 | DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES | FRC | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| December 20, 2010 | K102761 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | JOJ | Substantially Equivalent | Dana Products, Inc. | 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 |
| March 18, 2010 | K092944 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | FRC | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| January 25, 2008 | K073683 | VERIFY CHALLENGE PACKS - VERSION 2 | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 5, 2007 | K070895 | VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 3, 2002 | K002741 | BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| February 15, 1990 | K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | JOJ | Substantially Equivalent | Edward Weck, Inc. | accessdata.fda.gov |
| March 21, 1985 | K844512 | DART DAILY AIR REMOVAL TEST | JOJ | Substantially Equivalent | American Sterilizer Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2022 | 90763 | Class III | Terminated | Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design. | Product contains incorrect chemical indicators in packaging. | accessdata.fda.gov |
| December 7, 2011 | 60742 | Not yet classified | Terminated | STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Ster | Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perf | accessdata.fda.gov |
| March 14, 2011 | 58290 | Not yet classified | Terminated | STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critica | The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **steril | accessdata.fda.gov |
| September 12, 2007 | 44810 | Not yet classified | Terminated | Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 att | Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. The absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Sterilant, Medical Devices
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Indicator, Biological Sterilization Process
- All makers of Accessories, Cleaning, For Endoscope
- All makers of Accessories, Germicide, Cleaning, For Endoscopes
Updated October 2, 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.