STERIS Corporation

FDA Device Registration & Listing · Mentor, OH, US · Registration 3000251274

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
3000251274
FEI Number
3000251274
Entity Name
STERIS Corporation
City/State/Country
Mentor, OH, US
Establishment Address
6515 HOPKINS 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
N
Expiration Date (Year)
2026
510(k) Number
K173633
PMA Number
N/A

All Registered Proprietary Names

Verify HPU Chemical Indicator (PCC061) (LC-MF) Celerity HP Chemical Indicator (PCC074) (LC-CFE) Celerity HP Multivariable Chemical Indicator (PCC079) (LC-MF) Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD) Celerity HP Chemical Indicator (PCC075) (LC-MF) 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) VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD) VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-SD) SteriScan Reusable Test Pack without Counter (3306NC) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) VERIFY SixCess MF4 STEAM Emulating Indicator (FP-CFE) SteriScan Reusable Test Pack with Counter (3306) (FP-CFE) Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-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) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) SteriScan Reusable Test Pack (5500) (FP-CFE) VERIFY Bowie Dick Test Card (S3095) (HP-MF) VERIFY STEAM Integrating Indicator (PCC064 PCC065 PCC066) (FP-MF, HP-MF) 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) Celerity Xtend 10 Assembly (LCB054) (PC-CFE) VERIFY All-In-One Steam Reusable Test Pack with Tag (LCB057) (FP-MF, HP-MF) VERIFY All-In-One PV10 Assembly (LCB042) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB056) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) ConFirm Rapid 20 Incubator VERIFY SixCess 270F 4 Challenge Pack (LCC003) (HP-MF, LC-SD) VERIFY SixCess 275F 3 Challenge Pack (LCC014) (HP-MF, LC-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 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-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 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) VERIFY Bowie Dick Test Pack (EQC009) (HP-MF, LC-MF) VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB041) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB036) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack with Tag (LCB037) (FP-MF, HP-MF) VERIFY STEAM Integrating Indicator (PCC064 PCC065 PCC066) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack (LCB039) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB035) (FP-MF, HP-MF) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo 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) 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) 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 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) 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) Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD) VERIFY SixCess 270FP Challenge Pack (LCC019) (HP-MF, LC-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) 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 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) Reliance 5000 Series Endoscope Storage Cabinet (QB-RR) Connectors for Reliance 6000 Series Endoscope Storage Cabinet (QB-RR) Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (HP-MF, PY-SD) Drying Cabinet Connectors (QB-RR) AMSCO Drying Cabinets (QB-RR) Reliance 6500 Series Endoscope Drying and Storage Cabinet (MM-MF, PY-SD) Reliance 6000 Series Endoscope Storage Cabinet (QB-RR) Celerity HP Incubator (LCB046) SYSTEM 1 endo Quick Connects (HP-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD) VERIFY STEAM INTEGRATING INDICATOR 5CM (PCC067) (FP-MF, HP-MF) VERIFY STEAM Integrating Indicator (PCC064 PCC065 PCC066) (FP-MF, HP-MF) MCKESSON INTEGRATORS (FP-MF, HP-MF) SPS EMULATING INDICATORS (FP-MF, HP-MF) SPS Henry Schein Integrator (FP-MF, HP-MF) Hu-Friedy Steam Sterilization Integrator (FP-MF, HP-MF) SPS ENSURE (FP-MF, HP-MF) K Dental Indicators (FP-MF, HP-MF) Patterson Type 5 (FP-MF, HP-MF) SPS INTEGRATORS (FP-MF, HP-MF) HENRY SCHEIN MAXITEST INTEGRATORS (FP-MF, HP-MF) VERIFY All-In-One PV10 Assembly (LCB042) (FP-CFE) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF) SteriScan Reusable Extended Cycle Test Pack (4400) (FP-CFE) SPS SteamPlus Steam Integrator Ster-All Performance Steam Sterilization Integrator (FP-CM,HP-CM) McKesson Steam Integrator (FP-CM,HP-CM) Henry Schein Integrator (FP-CM,HP-CM) K-Dental Indicators (FP-CM,HP-CM) SPS EMULATING INDICATORS (FP-CM,HP-CM) SPS INTEGRATORS (FP-CM,HP-CM) SPS ENSURE (FP-CM,HP-CM) Patterson Type 5 (FP-CM,HP-CM) HENRY SCHEIN MAXITEST INTEGRATORS (FP-CM,HP-CM) MCKESSON STERILIZATION INTEGRATOR (FP-CM,HP-CM) SPS Henry Schein Integrator (FP-CM,HP-CM) Verify VH202 Indicator Tape (PCC071) (HP-RR, PC-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) Celerity HP Indicator Tape (PCC077) (HP-RR, PC-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) 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) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) VERIFY RESI-TEST Endo Cleaning Indicator (LCC101) (PC-MF) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small (2D73QH) (PC-MF) VERIFY RESI-TEST Swab Cleaning Indicator (LCC100) (PC-MF) Revital-Ox Single-Ended Channel Brush (2D75QV) (EN-MF) Instrument Cleaning Brushes, Other (HP-RR) Revital-Ox Valve/Control Brush (2D78QV) (EN-MF) Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium (2D74QH) (PC-MF) Cleaning brush - channel (EN-MF) Cleaning brush - channel - maxi (EN-MF) Double Header - channel and control head combo (EN-MF) Revital-Ox Dual-Ended Pull Through Channel Brush (2D76QH) (EN-MF) Cleaning brush - control head (EN-MF) Revital-Ox All-In-One Channel and Valve/Control Brush (2D77QH) (EN-MF) Small Wonder - cleaning brush (EN-MF) Cleaning brush - channel - enteroscope (EN-MF) Gemini - double ended - channel (EN-MF) DuoSwift Cleaning Brush (EN-MF) Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large (2D79QH) (PC-MF) Wooly Brush - channel (EN-MF) Small Wonder - Double Ended - cleaning brush (EN-MF) Instrument Cleaning Brushes (S-M) (HP-RR) Pipe Cleaners (LC-FE) Celerity Incubator (LCB060) S40 Sterilant Concentrate (MM-MF, CM-SD) SYSTEM 1E Trays and Containers (QB-MF, CM-SD) SYSTEM 1E Quick Connects (HP-MF, CM-SD) SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD) Celerity Incubator 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) VERIFY STEAM INTEGRATING INDICATOR 5CM (PCC067) (FP-MF, HP-MF) Celerity STEAM Incubator (LCB051) 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) Celerity Incubator (LCB060) Dart Daily Air Removal Test (NB113, NB215) (HP-MF) VERIFY All-In-One PV10 Assembly (LCB042) (FP-CFE) Celerity 20 STEAM Biological Indicator (LCB048) (PC-MF) VERIFY All-In-One STEAM Reusable Test Pack with Step Counter (LCB056) (FP-MF, HP-MF) VERIFY All-In-One Steam Reusable Test Pack with Tag (LCB057) (FP-MF, HP-MF) VERIFY All-In-One STEAM Reusable Test Pack (LCB055) (FP-MF, HP-MF)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2023-09-18
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator General Hospital Class 2 880.2800 2023-09-18
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-22
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-05-27
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2026-04-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2024-02-05
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2021-09-19
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-05-10
FEB Accessories, Cleaning, For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-03-23
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
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-22
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-10
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
PUP Endoscope Maintenance System Gastroenterology, Urology Class 2 876.1500 2024-03-13
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2021-05-26
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2022-01-25
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-08-25
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2023-10-22
NZA Accessories, Germicide, Cleaning, For Endoscopes Gastroenterology, Urology Class 2 876.1500 2023-09-15
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2020-10-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-07-28
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2022-08-21
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2024-10-15
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-22
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2020-10-13
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2025-03-23
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-10-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2020-10-12

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

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3018811167 MEDIVATORS INC Rogers, MN, US
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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
K151482 Bcr Diagnostics, Inc. BCR-30-min BI™ and RBIP-ST30™ Readout Accessory 2016-02-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000251274. Last updated year: 2026. Please use registration number 3000251274 when referencing this establishment in official correspondence.
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