Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1933443

FEI Number

1000510740

Entity Name

STERIS CORPORATION

City/State/Country

Breckenridge Hills, MO, US

Establishment Address

8525 Page Ave, Breckenridge Hills, MO 63114, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

STERIS Corporation (Owner Number: 10078069)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240075

PMA Number

N/A

All Registered Proprietary Names

STANDARD BASKET FOR ULTRA+ (MD-MF) Prolystica HP Enzymatic Automated Detergent (1C22) (SL-MF, SLDC-RR) Liqui Jet 2 (SL-CFE) Prolystica Ultra Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Valsure Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Neutral Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Alkaline Detergent (SL-MF, SLDC-RR) Prolystica 2X Concentrate Enzymatic Presoak and Cleaner (SL-MF, SLDC-RR) RTU Concentrated Z-Sponge RTU Foaming Z-Sponge Distal Duck Kit (MD-CFE) Prolystica HP Neutral Manual Cleaner (1C27) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner (1C24) (SL-MF, SLDC-RR) Prolystica HP Alkaline Automated Detergent (1C20) (SL-MF, SLDC-RR) InnoWave ECO ULTRASONIC CLEANER (5.3 GAL) (MD-MF) Valsure Enzymatic Cleaner (SL-MF, SLDC-RR) STANDARD BASKET FOR ULTRA (MD-MF) Valsure Neutral Detergent (SL-MF, SLDC-RR) InnoWave ECO 2.6 Gallon Standard Mesh Basket (MD-MF) 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE) Multi-Enzymatic Foaming Cleanser RTU InnoWave ULTRA SONIC IRRIGATOR (MD-MF) INSTRUMENT ORGANIZERS FOR PCF (MD-CFE) VERIFY DualAction Ultrasonic Indicator (DUI) (LCC027) Prolystica Ultra Concentrate HP Enzymatic Cleaner (1C16) (SL-MF, SLDC-RR) InnoWave Unity Sonic Irrigator (MD-MF) Renu Klenz (SL-MF, SLDC-RR) Multi-Enzymatic Cleaner (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA (MD-MF) Prolystica HP Alkaline Manual Cleaner (1C26) (SL-MF, SLDC-RR) Prolystica Ultra Concentrate HP Alkaline Detergent (1C17) (SL-MF, SLDC-RR) Prolystica HP Enzymatic Manual Cleaner Dye & Fragance (1C23) (SL-MF, SLDC-RR) InnoWave Unity 20 Sonic Irrigator (MD-MF) Klenzyme (SL-CFE) InnoWave ECO ULTRASONIC CLEANER (2.6 GAL) (MD-MF) Post Procedure Enzymatic Cleaning Kit InnoWave ULTRA+ SONIC IRRIGATOR (MD-MF) Prolystica HP Neutral Automated Detergent (1C21) (SL-MF, SLDC-RR) INSTRUMENT ORGANIZERS FOR InnoWave ULTRA+ (MD-MF) Prolystica Ultra Concentrate HP Neutral Detergent (1C15) (SL-MF, SLDC-RR) InnoWave ECO 5.3 Gallon Standard Mesh Basket (MD-MF) Non-Foaming Multi-Enzymatic Cleanser VERIFY DualAction Ultrasonic Indicator Holder (LCC028) Distal Tip Soakers (MD-CFE) Pre-Klenz Enzymatic Soak Shield Kit 2D66Q5, 2D66J3, 2D66J4, 2D66J6 (SL-MF) Revital-Ox Resert High Level Disinfectant (SL-MF, SLDC-RR) Prolystica Multi-Enzymatic Cleaner (1C38) Prolystica 100 PID Prion Inactivating Detergent 8E-Zyme Cleaner 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) Prolystica Pass-Thru Disinfectant Wipes (1C061D) (SL-SD, SLDC-RR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2020-10-09
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2020-10-09
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2020-10-09
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2020-10-10
NZA	Accessories, Germicide, Cleaning, For Endoscopes	Gastroenterology, Urology	Class 2	876.1500	2023-09-15
SHM	N/A	N/A	Class N/A	N/A	2026-06-05

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-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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3034286426	CIVCO Medical Instruments Co., Inc.	Coralville, IA, US
1527821	STERIS CORPORATION	Mentor, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1933443. Last updated year: 2026. Please use registration number 1933443 when referencing this establishment in official correspondence.