510(k) Report

Devices descending from K043482

8 later devices reach The Reliance PI Process Indicator, Model D5116 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063285Reliance CI Process IndicatorAlbert Browne, Ltd.20077—
+2K130160Verify Process Indicator for Reliance EpsSTERIS Corporation20130—
+2K102217System 1E Chemical IndicatorSTERIS Corporation20105—
+3K230558Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation20230—
+3K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation20183—
+4K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation20241—
+4K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…Steris20230—
+5K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation20240—