510(k) Report

Devices descending from K102217

5 later devices reach System 1E Chemical Indicator through their predicates, nearest generation first.

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