510(k) Report

Devices descending from K110028

89 later devices reach Masimo Radical Y Pulse CO-Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+1K161909IQvitals ZoneMidmark Corporation201614
+1K152043Diagnostic Station DS20Schiller AG20161—
+1K142915ZOLL X SeriesZOLL Medical Corporation20140—
+1K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+1K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+1K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+1K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+2K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+2K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+2K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+2K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+2K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+2K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+2K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+2K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+2K172890SedLine Sedation MonitorMasimo Corporation20185—
+2K170182Cardiovit FT-1Schiller AG20170—
+2K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+2K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+3K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+3K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+3K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+3K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+3K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+3K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+3K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+3K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+3K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+3K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+4K260880SedLine Sedation MonitorMasimo Corporation20260—
+4K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+4K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+4K241397HinscopeHinlab Sas20240—
+4K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K222550Current Health SystemCurrent Health, Ltd.20221—
+4K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+4K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+4K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+4K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+4K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+5K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+5K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+5K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+5K214115MightySat -OTCMasimo Corporation20241—
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K231506Current Health SystemCurrent Health, Ltd.20230—
+5K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+5K211632Pulse 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—
+5K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+5K191882Masimo Centroid SystemMasimo Corporation20203—
+5K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+5K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+5K181352Loop SystemSpry Health, Inc.201910—
+5K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+6K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K250515EpiMonitorEmpatica S.r.l.20250—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K240251ANNE ChestSibel Health, Inc.20240—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+6K223498Radius VSM and AccessoriesMasimo Corporation202312
+6K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+6K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+6K220351Polso WatchChronisense Medical, Ltd.20220—
+6K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+6K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+6K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+6K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K250757Radius VSM and AccessoriesMasimo Corporation20250—
+7K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+7K231531Pediarity™Hinlab, Inc.20230—
+7K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—