Data / Medical devices / United States / Steris Corporation

Steris Corporation: FDA-registered device maker in Saint Louis, 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 1937531) in Saint Louis, MO, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 2, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1937531
Address: 7501 Page Ave, Saint Louis, MO, United States, 63133
Owner or operator: STERIS Corporation (10078069)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
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	Manufacturer	accessdata.fda.gov
Accessories, Germicide, Cleaning, For Endoscopes	NZA	2	Manufacturer	accessdata.fda.gov
Basin For Endoscope Reprocessing	PHT	1	Complaint file establishment	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Complaint file establishment, Manufacturer, Manufacturer for export	accessdata.fda.gov
Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe	SHM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Manufacturer	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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 28, 2004	29263	Not yet classified	Terminated	STERIS Kindest Kare Perineal Cleanser Incontinence System, packaged in 4-fl. oz. bottles (72 per case), Ready-To-Use, No-Rinse Solution, For Pediatric and Geriatric Use, For Hospital and Professional Use Only. The label	The product failed microbial limits specification upon release and was distributed	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.