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STERIS Corporation

FDA 510(k) & PMA Approved Devices — 120 products

Total Devices120
Categories23
Latest FDA decision2026-06-24
TypeNumberDevice NameCodeDateActions
510(k) K261055 AMSCO 700 Steam SterilizerFLE2026-06-24 View
510(k) K251666 SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08 View
510(k) K260766 Celerity 5 HP Biological Indicator (LCB052)FRC2026-04-08 View
510(k) K252680 Celerity™ 20 HP Biological IndicatorFRC2025-09-24 View
510(k) K251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ2025-05-02 View
510(k) K243876 VERIFY STEAM Integrating IndicatorJOJ2025-04-25 View
510(k) K250842 PADLOCK CLIP EFTR Kit (00713229)PKL2025-04-18 View
510(k) K250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)FRC2025-02-06 View
510(k) K250061 Celerity IncubatorFRC2025-02-06 View
510(k) K243475 Chemical Indicator for enspire CLCSPS (LCC015)JOJ2024-12-04 View
510(k) K243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02 View
510(k) K243075 Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)ODC2024-11-08 View
510(k) K242742 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC2024-10-11 View
510(k) K240274 PADLOCK CLIP EFTR Kit (00713229)PKL2024-09-17 View
510(k) K240032 Celerity Chemical Indicator for enspire 3000 CLCSPSJOJ2024-04-17 View
510(k) K240352 Defendo Single Use Cleaning Adapter for Olympus EndoscopesODC2024-03-06 View
510(k) K240098 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC2024-02-09 View
510(k) K233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATEOVY2023-12-15 View
510(k) K233681 ConFirm 20 Minute IncubatorFRC2023-12-15 View
510(k) K232914 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)MED2023-10-03 View

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