510(k) Report

Devices descending from K040011

320 later devices reach Polaris 2004 Capnograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+10K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+11K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+11K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+11K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+11K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+11K240251ANNE ChestSibel Health, Inc.20240—
+11K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+11K223498Radius VSM and AccessoriesMasimo Corporation202312
+11K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+11K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+11K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+11K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+11K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+11K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+12K250757Radius VSM and AccessoriesMasimo Corporation20250—
+12K231531Pediarity™Hinlab, Inc.20230—
+12K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—