510(k) Report

Devices descending from K141877

5 later devices reach Leaf Patient Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233096PRESSUREALERT® Pressure Monitoring SystemPosition Health, LLC20240—
+1K191882Masimo Centroid SystemMasimo Corporation20203—
+2K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+2K223498Radius VSM and AccessoriesMasimo Corporation202312
+3K250757Radius VSM and AccessoriesMasimo Corporation20250—