510(k) Report

Devices descending from K060065

250 later devices reach CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K214115MightySat -OTCMasimo Corporation20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+9K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+9K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+9K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+9K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+9K191882Masimo Centroid SystemMasimo Corporation20203—
+9K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+9K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+9K181352Loop SystemSpry Health, Inc.201910—
+9K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+10K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+10K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K240251ANNE ChestSibel Health, Inc.20240—
+10K232445CSF-4 (CSF-4)Cardiacsense20240—
+10K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+10K223498Radius VSM and AccessoriesMasimo Corporation202312
+10K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+10K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+10K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+10K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+10K220351Polso WatchChronisense Medical, Ltd.20220—
+10K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+10K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+10K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+10K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+11K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+11K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+11K250757Radius VSM and AccessoriesMasimo Corporation20250—
+11K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+11K231531Pediarity™Hinlab, Inc.20230—
+11K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—