510(k) Report

Devices descending from K132060

5 later devices reach Durablue Sterilization Wrap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151788Cardinal Health Sterilization WrapCardinal Health200, LLC20154—
+2K181174Cardinal Health Sterilization WrapCardinal Health200, LLC20183—
+3K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.20241—
+3K222151Sterilization WrapKenpax International Limited20230—
+4K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.20240—