510(k) Report

Devices descending from K070582

5 later devices reach Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C.… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153655Accuryn Monitoring SystemPotrero Medical, Inc.20164—
+2K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn…Potrero Medical, Inc.20230—
+2K210570TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC20212—
+3K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC20241—
+4K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,20260—