Data / Medical devices / United States / Steris Corporation
Steris Corporation: FDA-registered device maker in Mentor, OH, United States, 69 510(k) clearances
Steris Corporation is registered with the FDA (registration 3004080920) in Mentor, OH, United States. It lists 12 device types. The FDA files 69 510(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
- 3004080920
- Address
- 9325 Pinecone Drive, Mentor, OH, United States, 44060
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- February 14, 2013
- Registered through
- 2027
- Brand names listed
- Alyon Standard Light Handle (MG-MF), Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD), Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-SD CFE, MM-RR), Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-SD CFE, MM-RR), Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-SD CFE, MM-RR), Celerity 20 HP Biological Indicator (LCB044), Celerity 20 HP Biological Indicator (LCB044, LCB045, LCB047), Celerity 20 HP Challenge Pack (LCB045) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Block, Heating | JRG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Indicator, Biological, Liquid Chemical Sterilization Process | MRB | 2 | Manufacturer for export | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Liquid Chemical Processing System | OVY | 2 | Manufacturer | accessdata.fda.gov |
| Qualitative Cleaning Process Protein Indicator | SDC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Repackager or relabeler, Specification developer | 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 | K260766 | Celerity 5 HP Biological Indicator (LCB052) | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 6, 2025 | K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | Substantially Equivalent | Steris | accessdata.fda.gov |
| February 6, 2025 | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | 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 16, 2024 | K242839 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 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 | K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | OVY | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 11, 2023 | K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | OVY | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 7, 2023 | K231501 | PRO-LITE Sterilization Tray | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 7, 2023 | K231500 | Vis-U-All Low Temperature Sterilization Pouches | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 7, 2023 | K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | FRC | 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 |
| June 15, 2023 | K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 9, 2022 | K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays | FRG | Substantially Equivalent | Steris | accessdata.fda.gov |
| March 18, 2022 | K220473 | CELERITY 20 HP Challenge Pack | FRC | Substantially Equivalent | Steris | accessdata.fda.gov |
| January 8, 2021 | K202721 | Celerity 20 Steam Biological Indicator for IUSS | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 22, 2020 | K200126 | VERIFY Assert Self-Contained Biological Indicator | FRC | 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 |
| March 1, 2019 | K183402 | PRO-LITE Sterilization Tray | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 1, 2019 | K183401 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 4, 2019 | K183293 | VERIFY VH202 Indicator Tape | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K183301 | PRO-LITE Sterilization Tray | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | FRC | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| January 3, 2019 | K183297 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 3, 2019 | K180139 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Safe Secure Packing Co., Ltd. | 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 |
| June 13, 2018 | K181429 | CELERITY 20 HP Biological Indicator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 29, 2018 | K180553 | VERIFY Spore Test Strip for S40 Sterilant | OVY | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 1, 2018 | K173488 | CELERITY 20 HP Challenge Pack | FRC | 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 21, 2018 | K173629 | CELERITY 20 Steam Process Challenge Device for Gravity Cycles | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 21, 2018 | K173626 | Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles | 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 | K172755 | PRO-LITE Sterilization Trays | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172753 | VERIFY VH2O2 Indicator Tape | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172752 | CELERITY 20 HP Biological Indicator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172749 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | FRC | Substantially Equivalent | Steris Corporations | accessdata.fda.gov |
| December 29, 2017 | K172474 | Celerity 20 HP Biological Indicator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 22, 2017 | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 28, 2017 | K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 7, 2016 | K160912 | Sterilization Tray | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 4, 2016 | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | FRG | Substantially Equivalent | Safe Secure Packaging Co., Ltd. | accessdata.fda.gov |
| July 22, 2016 | K160908 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 1, 2016 | K160485 | VERIFY VH2O2 Indicator Tape | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 25, 2014 | K140494 | V-PRO STERILIZATION TRAY/ STERILIZATION MAT | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 22, 2014 | K140487 | VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 17, 2014 | K140499 | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 16, 2014 | K140708 | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 30, 2012 | DEN110002 | SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT | OVY | Unknown | STERIS Corporation | accessdata.fda.gov |
| September 1, 2011 | K103331 | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 18, 2011 | K103226 | STERILIZATION MATS | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 19, 2010 | K092745 | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 30, 2009 | K092906 | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 1, 2009 | K083665 | VERIFY SCBI 275F 3-10 | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| May 1, 2009 | K090371 | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 16, 2009 | K090514 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 7, 2009 | K073618 | VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK | FRC | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 16, 2007 | K071087 | VIS-U-ALL II HEAT-SEAL POUCH AND TUBING | FRG | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 12, 2007 | K070765 | VIS-U-ALL II SELF SEAL POUCH | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 5, 2007 | K070769 | VHP 136 TRAY | KCT | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| October 20, 2005 | K051056 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| December 17, 1986 | K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | FRC | Substantially Equivalent | Surgicot, Inc. | accessdata.fda.gov |
| July 17, 1986 | K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | FRC | Substantially Equivalent | Surgicot, Inc. | accessdata.fda.gov |
| May 20, 1986 | K854902 | SURGICOT STEAM TEST PACK | FRC | Substantially Equivalent | Surgicot, Inc. | accessdata.fda.gov |
| March 12, 1980 | K800029 | SURGICOT 2 INDICATOR SYSTEM | FRC | Substantially Equivalent | Surgicot, Inc. | accessdata.fda.gov |
Compare with other makers
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- All makers of Indicator, Physical/Chemical Sterilization Process
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.