510(k) Report

Devices descending from K063285

7 later devices reach Reliance CI Process Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130160Verify Process Indicator for Reliance EpsSTERIS Corporation20130—
+1K102217System 1E Chemical IndicatorSTERIS Corporation20105—
+2K230558Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation20230—
+2K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation20183—
+3K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation20241—
+3K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…Steris20230—
+4K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation20240—