510(k) Report

Devices descending from K131966

7 later devices reach Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20206—
+2K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20205—
+3K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc.202141
+4K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG20230—
+4K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20222—
+5K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20251—
+6K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20260—