510(k) Report

Devices descending from K914145

34 later devices reach DSD-91(TM) Disinfector for Flexible Endoscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092387Medivators DSD Edge Endoscope Reprocessing SystemMinntech Corp.201001
+1K093106Endoscope Reprocessor Oer-ProOlympus Medical Systems Corporation20105—
+1K063876Modular Disinfection System (MDS) for Endoscope ReprocessingMedivators Reprocessing Systems20078—
+1K051305CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Cs Medical, LLC20059—
+1K040883Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products2005183
+2K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…Cs Medical, LLC20162—
+2K150504GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal…Pci Medical, Inc.20151—
+2K103059TrophonNanosonics Limited201131
+2K103264Endoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation201146
+2K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems200974
+2K061899Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products2006172
+3K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12…Cs Medical, LLC20201—
+3K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.201911
+3K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp)20190—
+3K173865trophon2Nanosonics Limited20182—
+3K172677Advantage Plus Pass-ThruMedivators, Inc.201701
+3K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe…CIVCO Medical Instruments Co., Inc.20170—
+3K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc.20162—
+3K123768Reliance Advance Endoscope Processing SystemSTERIS Corporation20132—
+3K120357Endoscope Reprocessor Oer-MiniOlympus Medical Systems Corp.201202
+3K102996Medivators Advantage Plus Endoscope ReprocessorMedivators Reprocessing Systems201114
+3K082392Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products200843
+4K250434trophon2Nanosonics20250—
+4K251035DISINTEK™ PA Test StripsSerim Research20250—
+4K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation20250—
+4K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited20240—
+4K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with…Cs Medical, LLC20230—
+4K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation20231—
+4K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.2020016
+4K140977Evotech EcrAdvanced Sterilization Products201433
+5K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation20230—
+5K152189Evotech EcrAdvanced Sterilization Products (Asp)201621
+6K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation20231—
+7K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation20240—