STERIS Corporation - FDA 510(k) Cleared Devices

Cleared Sep 24, 2025

Celerity™ 20 HP Biological Indicator

K252680 · FRC

General Hospital · 30d

Cleared May 02, 2025

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

K251048 · JOJ

General Hospital · 29d

Cleared Apr 25, 2025

VERIFY STEAM Integrating Indicator

K243876 · JOJ

General Hospital · 128d

Cleared Feb 06, 2025

Celerity 5 HP Biological Indicator (LCB052)

K250044 · FRC

General Hospital · 27d

Cleared Feb 06, 2025

Celerity Incubator

K250061 · FRC

General Hospital · 27d

Cleared Dec 04, 2024

Chemical Indicator for enspire CLCSPS (LCC015)

K243475 · JOJ

General Hospital · 26d

Cleared Dec 02, 2024

enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System

K243433 · FEB

General Hospital · 27d

Cleared Apr 17, 2024

Celerity Chemical Indicator for enspire 3000 CLCSPS

K240032 · JOJ

General Hospital · 104d

Cleared Dec 15, 2023

ConFirm 20 Minute Incubator

K233681 · FRC

General Hospital · 29d

Cleared Dec 15, 2023

VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE

K233682 · OVY

General Hospital · 29d

Cleared Oct 03, 2023

SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500)

K232914 · MED

General Hospital · 14d

Cleared Oct 03, 2023

enspire 300 Series Automated Endoscope Reprocessor

K232918 · NZA

General Hospital · 14d