STERIS Corporation

FDA Device Registration & Listing · Mentor, OH, US · Registration 3003950207

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003950207
FEI Number
3003950207
Entity Name
STERIS Corporation
City/State/Country
Mentor, OH, US
Establishment Address
6100 Heisley Rd, Mentor, OH 44060, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STERIS Corporation (Owner Number: 10078069)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K232918
PMA Number
N/A

All Registered Proprietary Names

V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-SD CFE, MM-RR) VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (LCC101) (PC-SD CFE, MM-RR) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-SD CFE, MM-RR) Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-SD CFE, MM-RR) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) Amsco V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) Reliance DG Germicide (D5100) (MM-CFE) Reliance EPS Endoscope Processing System (QB-CFE) Flow Units (#1-11) (QB-MF) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) Reliance HLD (5109) (MM-CFE) Reliance DG Dry Germicide (5100) (MM-CFE) Flow Unit 3 (QB-MF) Flow Unit 1 (QB-MF) Flow Unit 2 (QB-MF) Flow Unit 4 (QB-MF) Flow Unit 7 (QB-MF) Flow Unit 5 (QB-MF) Flow Unit 9 (QB-MF) Reliance EPS Endoscope Processing System (QB-CFE) Flow Unit 6 (QB-MF) Flow Unit 8 (QB-MF) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (MM-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) enspire 3000 MaxFlow connectors (HP-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) Amsco V-PRO 1 Low Temperature Sterilization Systems (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) Reliance EPS Endoscope Processing System (QB-CFE) Flow Units (#1-11) (QB-MF) Reliance DG Germicide (D5100) (MM-CFE) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) Reliance EPS Endoscope Processing System (QB-CFE) Flow Units (#1-11) (QB-MF) Reliance DG Dry Germicide (5100) (MM-CFE) enspire 300 Series Connectors (HP-MF) RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR) enspire 300 Series Automated Endoscope Reprocessor (QB-MF) RevitalOx PAA HLD Solution Part A (MM-MF) V-PRO maX Low Temperature Sterilization System (MY-CFE, CM-SD) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) V-PRO 60 Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) VAPROX HC Sterilant (PB011 and PB012) (MM-MF, CM-SD) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) RevitalOx PAA HLD Solution Part B (SL-MF, SLDC-RR) enspire 300 Series Connectors (HP-MF) enspire 300 Series Automated Endoscope Reprocessor (QB-MF) RevitalOx PAA HLD Solution Part A (MM-MF)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2023-10-26
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
SDC Qualitative Cleaning Process Protein Indicator General Hospital Class 2 880.6930 2024-11-26
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2022-03-30
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
FEB Accessories, Cleaning, For Endoscope Gastroenterology, Urology Class 2 876.1500 2023-09-14
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2024-10-15
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2022-10-15
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2021-03-12
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2026-04-09
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2023-10-22
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2020-10-13
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2023-09-15
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2022-09-15
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2020-10-13
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2023-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033381 Discus Dental, Inc. DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL 2004-01-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2014 Advanced Sterilization Products 2
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014 Advanced Sterilization Products 2
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003950207. Last updated year: 2026. Please use registration number 3003950207 when referencing this establishment in official correspondence.
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