510(k) Report

Devices descending from K040214

254 later devices reach Modification to: Masimo Set Radical Pulse Oximeter with Satshare and Lnop… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+9K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+9K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+9K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+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—
+9K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+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—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+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—
+10K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+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
+10K233216CLEWICU SystemClew Medical, Ltd.20240—
+10K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+10K223498Radius VSM and AccessoriesMasimo Corporation202312
+10K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+10K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+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—
+10K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+10K212219AHI SystemFifth Eye, Inc.20211—
+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—
+11K260008Deterioration Index Version 2Epic Systems Corporation20260—
+11K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+11K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+11K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+11K250757Radius VSM and AccessoriesMasimo Corporation20250—
+11K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+11K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+11K231531Pediarity™Hinlab, Inc.20230—
+11K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+11K221203AHI SystemFifth Eye, Inc.20220—
+11K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—