510(k) Report

Devices descending from K982776

425 later devices reach 9303 Neonatal/Adult Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K231506Current Health SystemCurrent Health, Ltd.20230—
+12K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+12K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+12K191882Masimo Centroid SystemMasimo Corporation20203—
+12K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+12K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+12K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+13K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+13K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+13K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+13K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+13K240251ANNE ChestSibel Health, Inc.20240—
+13K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+13K223498Radius VSM and AccessoriesMasimo Corporation202312
+13K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+13K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+13K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+13K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+13K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+13K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+14K250757Radius VSM and AccessoriesMasimo Corporation20250—
+14K231531Pediarity™Hinlab, Inc.20230—
+14K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—