510(k) Report

Devices descending from K112211

11 later devices reach Dura Blue Sterilization Wrap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123289Durablue Sterilization WrapCardinal Health-Medical Products and Services20137—
+1K120658Durablue Sterilization WrapCardinal Health200, LLC20129—
+2K132060Durablue Sterilization WrapCardinal Health-Medical Products and Services20135—
+2K130927Durablue Sterilization WrapCardinal Health200, LLC20130—
+2K122507Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600…Cardinal Health200, LLC20128—
+3K151788Cardinal Health Sterilization WrapCardinal Health200, LLC20154—
+3K123857Durablue Sterilization WrapCardinal Health200, LLC20137—
+4K181174Cardinal Health Sterilization WrapCardinal Health200, LLC20183—
+5K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.20241—
+5K222151Sterilization WrapKenpax International Limited20230—
+6K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.20240—