# STERIS Corporation

- Location (FDA's records): Mentor, OH
- FDA decisions: 228 (1997–2026): 224 510(k) clearances and 4 De Novo grants
- Names in FDA's records: STERIS Corporation (205); Steris (22); Steris Corp (1)
- Product codes: JOJ (42), FRC (35), FLE (23), MLR (20), MED (19), KCT (11), NZA (9), FRG (8), ODC (7), NVE (5), OWP (5), OVY (4)
- 510(k) review time since 2016: median 89 days, against 130 for FDA's reviews in the same codes and years (69 of 101 faster)
- Predicates its devices cite: 290 (201 its own); citations of its devices by later devices: 247 (201 its own)
- Recalls linked to its devices: 44 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Sterilization Products: 14 (https://510kreport.com/company/advanced-sterilization-products)
- Albert Browne, Ltd.: 12 (https://510kreport.com/company/albert-browne)
- United States Endoscopy Group, Inc.: 6 (https://510kreport.com/company/united-states-endoscopy-group)
- 3M Company: 5 (https://510kreport.com/company/3m)
- Surgicot, Inc.: 4 (https://510kreport.com/company/surgicot)
- Dana Products, Inc.: 4 (https://510kreport.com/company/dana-products)
- Steritec Products Mfg Co, Inc.: 3 (https://510kreport.com/company/steritec-products-mfg)
- Pymah Corp.: 3 (https://510kreport.com/company/pymah)

## Firms that cite its devices most
- Steris Corporations: 5 (https://510kreport.com/company/steris-corporations)
- Medivators (A Subsidiary of Steris Corporation): 4 (https://510kreport.com/company/medivators-a-subsidiary-of-steris)
- Tso3, Inc.: 3 (https://510kreport.com/company/tso3)
- Sterilucent, Inc.: 2 (https://510kreport.com/company/sterilucent)
- Propper Mfg. Co., Inc.: 2 (https://510kreport.com/company/propper-mfg)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Ortho Kinematics, Inc.: 2 (https://510kreport.com/company/ortho-kinematics)
- Steris Corparation: 2 (https://510kreport.com/company/steris-corparation)

## Its most-cited devices
- K062297: VHP 136 Low Temperature Sterilization System (2007), cited by 8
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System (2009), cited by 6
- K102330: Amsco V-Pro Max Low Temperature Sterilization System (2011), cited by 5
- K072072: Harmony Led-1 Surgical Lighting System (2007), cited by 5
- K090036: System 1.5 Sterile Processing System (2010), cited by 4
- K092823: Amsco Warming Cabinet (2009), cited by 4

## Recent decisions
- K261791: MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor (Oct 2, 2026)
- K261055: AMSCO 700 Steam Sterilizer (Jun 24, 2026)
- DEN240075: Prolystica Pass Thru Disinfectant Wipes (May 1, 2026)
- K251666: SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (Apr 8, 2026)
- K260766: Celerity 5 HP Biological Indicator (LCB052) (Apr 8, 2026)
- K252680: Celerity™ 20 HP Biological Indicator (Sep 24, 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) (Jun 6, 2025)
- K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118 (May 2, 2025)

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