510(k) Report

Devices descending from K950388

321 later devices reach Polaris through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+11K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+11K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+12K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+12K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+12K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+12K240251ANNE ChestSibel Health, Inc.20240—
+12K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+12K223498Radius VSM and AccessoriesMasimo Corporation202312
+12K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+12K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+12K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+12K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+12K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+12K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+13K250757Radius VSM and AccessoriesMasimo Corporation20250—
+13K231531Pediarity™Hinlab, Inc.20230—
+13K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—