Data / Medical devices / United States / STERIS Corporation
STERIS Corporation: FDA-registered device maker in Franklin Park, IL, United States, 14 510(k) clearances
STERIS Corporation is registered with the FDA (registration 3007412809) in Franklin Park, IL, United States. It lists 2 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 25, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007412809
- Address
- 11457 Melrose Ave, Franklin Park, IL, United States, 60131
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- October 12, 2020
- Registered through
- 2027
- Brand names listed
- Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD), 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 Challenge Pack (PCC083) (PC-UMXD), Celerity Xtend 10 Assembly (LCB054) (PC-CFE), HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM, HP-CM), HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Biological Sterilization Process | FRC | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | 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 25, 2025 | K243876 | VERIFY STEAM Integrating Indicator | JOJ | 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 |
| 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 |
| 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 |
| January 27, 2017 | K162631 | VERIFY STEAM Integrating Indicator - Short | 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 |
| February 27, 2013 | K120592 | DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS | JOJ | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
| April 29, 2011 | K110253 | REUSABLE TEST PACK FOR DANA EMULATING INDICATORS | JOJ | Substantially Equivalent | Dana Products, Inc. | 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 |
| January 13, 2011 | K100891 | DANA EMULATING INDICATOR | JOJ | 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 |
| March 18, 2010 | K092944 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | FRC | Substantially Equivalent | Dana Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Biological Sterilization Process
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated April 25, 2025. 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.