Medical Device Manufacturer · US , Mentor , OH

STERIS Corporation

202 submissions · 200 cleared · Since 1997
202
Total
200
Cleared
2
Denied

STERIS Corporation — FDA 510(k) Submissions

STERIS Corporation has submitted 202 FDA 510(k) premarket notifications since 1997, of which 200 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator, Physical/chemical Sterilization Process, Indicator, Biological Sterilization Process, Sterilizer, Steam, Sterilant, Medical Devices, Sterilizer, Chemical . Use the specialty filter in the sidebar to narrow results.

202 devices
1–25 of 202
Celerity? 20 HP Biological Indicator
K252680 · FRC Indicator, Biological... · General Hospital
Sep 2025 30d
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · JOJ Indicator,... · General Hospital
May 2025 29d
VERIFY STEAM Integrating Indicator
K243876 · JOJ Indicator,... · General Hospital
Apr 2025 128d
PADLOCK CLIP EFTR Kit (00713229)
K250842 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Apr 2025 29d
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
K250044 · FRC Indicator, Biological... · General Hospital
Feb 2025 27d
Celerity Incubator
K250061 · FRC Indicator, Biological... · General Hospital
Feb 2025 27d
Chemical Indicator for enspire CLCSPS (LCC015)
K243475 · JOJ Indicator,... · General Hospital
Dec 2024 26d
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · FEB Accessories, Cleaning,... · General Hospital
Dec 2024 27d
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
K243075 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Nov 2024 42d
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K242742 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Oct 2024 30d
PADLOCK CLIP EFTR Kit (00713229)
K240274 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Sep 2024 230d
Celerity Chemical Indicator for enspire 3000 CLCSPS
K240032 · JOJ Indicator,... · General Hospital
Apr 2024 104d
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
K240352 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Mar 2024 30d
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K240098 · ODC Endoscope Channel Accessory · Gastroenterology & Urology
Feb 2024 28d
ConFirm 20 Minute Incubator
K233681 · FRC Indicator, Biological... · General Hospital
Dec 2023 29d
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
K233682 · OVY Liquid Chemical... · General Hospital
Dec 2023 29d
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
K232914 · MED Sterilant, Medical Devices · General Hospital
Oct 2023 14d
enspire 300 Series Automated Endoscope Reprocessor
K232918 · NZA Accessories, Germicide,... · General Hospital
Oct 2023 14d
VERIFY Spore Test Strip for S40 Sterilant Concentrate
K231746 · OVY Liquid Chemical... · General Hospital
Sep 2023 88d
V-PRO maX 2 Low Temperature Sterilization System
K223476 · MLR Sterilizer, Chemical · General Hospital
Aug 2023 262d
Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
K231490 · FRC Indicator, Biological... · General Hospital
Aug 2023 76d
Vis-U-All Low Temperature Sterilization Pouches
K231500 · FRG Wrap, Sterilization · General Hospital
Aug 2023 75d
PRO-LITE Sterilization Tray
K231501 · KCT Sterilization Wrap... · General Hospital
Aug 2023 75d
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
K231878 · FGB Ureteroscope And... · Gastroenterology & Urology
Jul 2023 29d
enspire 300 Series Automated Endoscope Reprocessor System
K230560 · NZA Accessories, Germicide,... · General Hospital
Jul 2023 143d

Looking for a specific device from STERIS Corporation? Search by device name or K-number.

Search all STERIS Corporation devices
Filters