STERIS Corporation - FDA 510(k) Cleared Devices
Recent clearances: SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700, Celerity 5 HP Biological Indicator (LCB052), Celerity™ 20 HP Biological Indicator
204
Total
202
Cleared
2
Denied
FDA 510(k) Regulatory Record - STERIS Corporation General Hospital ✕
175 devices
Cleared
Apr 08, 2026
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700
General Hospital
313d
Cleared
Apr 08, 2026
Celerity 5 HP Biological Indicator (LCB052)
General Hospital
30d
Cleared
Sep 24, 2025
Celerity™ 20 HP Biological Indicator
General Hospital
30d
Cleared
May 02, 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
General Hospital
29d
Cleared
Apr 25, 2025
VERIFY STEAM Integrating Indicator
General Hospital
128d
Cleared
Feb 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
General Hospital
27d
Cleared
Feb 06, 2025
Celerity Incubator
General Hospital
27d
Cleared
Dec 04, 2024
Chemical Indicator for enspire CLCSPS (LCC015)
General Hospital
26d
Cleared
Dec 02, 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
General Hospital
27d
Cleared
Apr 17, 2024
Celerity Chemical Indicator for enspire 3000 CLCSPS
General Hospital
104d
Cleared
Dec 15, 2023
ConFirm 20 Minute Incubator
General Hospital
29d
Cleared
Dec 15, 2023
VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
General Hospital
29d
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