510(k) Report

Devices descending from K922481

22 later devices reach Browne GA Indicator Use in 2% Activ Glutaraldehyde through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012335Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…Albert Browne, Ltd.200110—
+1K991709Browne Cidex Opa IndicatorAlbert Browne, Ltd.199961
+1K984616Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting…Albert Browne, Ltd.19990—
+1K984613Browne Sporicidin Phenol Indicator for Sporicidin Sterilizing and Disinfecting SolutionAlbert Browne, Ltd.19990—
+1K981054Browne GA Indicator for Cidex ProductsAlbert Browne, Ltd.199813
+2K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp)20190—
+2K172472Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation20170—
+2K083295Serim Disintek Gta 2.1%, Model: 5164Serim Research Corp.20090—
+2K081600Steris Resert XL Test StripSTERIS Corporation20088—
+2K081370Serim Disintek Opa Test StripSerim Research Corp.20082—
+2K081427Browne Opa Test StripSTERIS Corporation20082—
+3K241344MetriCide™ OPA Plus Solution Test StripSteris20240—
+3K202565WAVICIDE-OPA MEC IndicatorSerim Research Corporation20200—
+3K120652Rapicide Opa-28 Test StripSerim Research Corp.20120—
+3K102296Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2)STERIS Corporation20111—
+3K102217System 1E Chemical IndicatorSTERIS Corporation20105—
+4K230558Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation20230—
+4K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation20183—
+4K143333Revital-Ox RESERT Solution Test StripSTERIS Corporation20150—
+5K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation20241—
+5K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…Steris20230—
+6K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation20240—