510(k) Report

Devices descending from K153655

4 later devices reach Accuryn Monitoring System through their predicates, nearest generation first.

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