510(k) Report

Devices descending from K991487

25 later devices reach Cidex Opa Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032959Cidex Opa ConcentrateAdvanced Sterilization Products20050—
+1K040883Evotech Integrated Endoscope Disinfection SystemAdvanced Sterilization Products2005183
+1K0300040.55% Orth-Phthalaldehyde SolutionAdvanced Sterilization Products200362
+2K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical…Cs Medical, LLC20162—
+2K120306Rapicide Opa-28Minntech Corp.20123—
+2K070627Opaciden SolutionCiden Technologies, LLC20075—
+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—
+3K140703Opa 30 SolutionCiden Technologies, LLC20140—
+3K123768Reliance Advance Endoscope Processing SystemSTERIS Corporation20132—
+3K102996Medivators Advantage Plus Endoscope ReprocessorMedivators Reprocessing Systems201114
+3K082988Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level…Medivators Reprocessing Systems200974
+3K082392Evotech Endoscope Cleaner and ReprocessorAdvanced Sterilization Products200843
+4K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with…Cs Medical, LLC20230—
+4K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation20231—
+4K172677Advantage Plus Pass-ThruMedivators, Inc.201701
+4K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc.20162—
+4K140977Evotech EcrAdvanced Sterilization Products201433
+4K092387Medivators DSD Edge Endoscope Reprocessing SystemMinntech Corp.201001
+5K251035DISINTEK™ PA Test StripsSerim Research20250—
+5K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation20250—
+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—