Data / Medical devices / United States / Steris Corporation

Steris Corporation: FDA-registered device maker in Breckenridge Hills, MO, United States, 6 510(k) clearances

Name: Steris Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Steris Corporation is registered with the FDA (registration 1933443) in Breckenridge Hills, MO, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 2, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1933443
FEI number: 1000510740
Address: 8525 Page Ave, Breckenridge Hills, MO, United States, 63114
Owner or operator: STERIS Corporation (10078069)
Roles: Manufacturer for export, Repackager or relabeler
First device listed: October 9, 2020
Registered through: 2027
Brand names listed: 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE), 8E-Zyme Cleaner, Caviwave Ultrasonic Cleaner (MD-CFE), Connectors for MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (PY-SD, HP-RR), Distal Duck Kit (MD-CFE), Distal Tip Soakers (MD-CFE), INSTRUMENT ORGANIZERS FOR InnoWave ULTRA (MD-MF), INSTRUMENT ORGANIZERS FOR InnoWave ULTRA+ (MD-MF) and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning, For Endoscope	FEB	2	Repackager or relabeler	accessdata.fda.gov
Accessories, Germicide, Cleaning, For Endoscopes	NZA	2	Repackager or relabeler	accessdata.fda.gov
Basin For Endoscope Reprocessing	PHT	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe	SHM	2	Repackager or relabeler	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 2, 2026	K261791	MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor	FEB	Substantially Equivalent	Steris	accessdata.fda.gov
May 1, 2026	DEN240075	Prolystica Pass Thru Disinfectant Wipes	SHM	Unknown	Steris	accessdata.fda.gov
October 3, 2023	K232918	enspire 300 Series Automated Endoscope Reprocessor	NZA	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
July 21, 2023	K230560	enspire 300 Series Automated Endoscope Reprocessor System	NZA	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
April 12, 2010	K091022	MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT	MED	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
September 2, 2008	K080420	RESERT XL HLD HIGH LEVEL DISINFECTANT	MED	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov

Compare with other makers

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.