510(k) Report

Devices descending from K893221

431 later devices reach Model 8500 Hand Held Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+13K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+13K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+13K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+13K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+13K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+13K231506Current Health SystemCurrent Health, Ltd.20230—
+13K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+13K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+13K191882Masimo Centroid SystemMasimo Corporation20203—
+13K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+13K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+13K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+14K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+14K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+14K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+14K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+14K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+14K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+14K240251ANNE ChestSibel Health, Inc.20240—
+14K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+14K223498Radius VSM and AccessoriesMasimo Corporation202312
+14K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+14K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+14K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+14K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+14K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+14K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+15K250757Radius VSM and AccessoriesMasimo Corporation20250—
+15K231531Pediarity™Hinlab, Inc.20230—
+15K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—