510(k) Report

Devices descending from K003289

6 later devices reach Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070582Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing…C.R. Bard, Inc.200754
+2K153655Accuryn Monitoring SystemPotrero Medical, Inc.20164—
+3K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn…Potrero Medical, Inc.20230—
+3K210570TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC20212—
+4K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC20241—
+5K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,20260—