# Steris Corporations

- Location (FDA's records): Mentor, OH
- FDA decisions: 7 (2018–2021): 7 510(k) clearances
- Product codes: FRC (3), MED (2), JOJ (1), ODC (1)
- 510(k) review time since 2016: median 38 days, against 93 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- STERIS Corporation: 5 (https://510kreport.com/company/steris)
- United States Endoscopy Group, Inc.: 1 (https://510kreport.com/company/united-states-endoscopy-group)

## Firms that cite its devices most
- STERIS Corporation: 3 (https://510kreport.com/company/steris)
- 3M Company: 1 (https://510kreport.com/company/3m)

## Its most-cited devices
- K183300: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (2019), cited by 1
- K180342: SYSTEM 1E Liquid Chemical Sterilant Processing System (2018), cited by 1
- K183295: Celerity HP Chemical Indicator (CI) (2019), cited by 1
- K190104: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System (2019), cited by 1
- 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 (2018), cited by 1
- K172748: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (2018), cited by 1

## Recent decisions
- K203630: BioGuard Air/Water and Suction Valves (Jan 8, 2021)
- K190104: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System (Mar 22, 2019)
- K183295: Celerity HP Chemical Indicator (CI) (Jan 4, 2019)
- K183300: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (Jan 3, 2019)
- 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 (Nov 20, 2018)
- K180342: SYSTEM 1E Liquid Chemical Sterilant Processing System (Apr 4, 2018)
- K172748: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (Feb 9, 2018)

Source page: https://510kreport.com/company/steris-corporations