510(k) Report

Devices descending from K092463

3 later devices reach Sorin B-CARE5 for the Stockert S5 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103168B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)Sorin Group Deutschland GmbH20112—
+2K202154B-CaptaLivanova Deutschland, GmbH20211—
+3K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH202301