510(k) Report

Devices descending from K031740

290 later devices reach VSM - Vital Signs Monitor, Model 53000 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+6K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+7K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+7K241397HinscopeHinlab Sas20240—
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K214115MightySat -OTCMasimo Corporation20241—
+7K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K212271smart-syncNorthh Medical GmbH20220—
+7K211632Pulse 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—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+7K191882Masimo Centroid SystemMasimo Corporation20203—
+7K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+7K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+8K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K223721Masimo StorkMasimo Corporation20230—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K223498Radius VSM and AccessoriesMasimo Corporation202312
+8K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K231531Pediarity™Hinlab, Inc.20230—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—