510(k) Report

Devices descending from K951193

421 later devices reach Clinical Vital Signs Monitor, Model #52STP-E1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+7K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+7K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+7K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+7K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+7K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+7K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+7K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+7K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K170182Cardiovit FT-1Schiller AG20170—
+7K161056Telemetry TransmitterEdan Instruments, Inc.201702
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+7K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+7K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+7K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+7K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+7K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+7K140430740 SelectCas Medical Systems, Inc.20141—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+7K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+7K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+7K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+7K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+7K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K250757Radius VSM and AccessoriesMasimo Corporation20250—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+8K241397HinscopeHinlab Sas20240—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K231531Pediarity™Hinlab, Inc.20230—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K211632Pulse 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—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+8K202375ZOLL Propaq MZOLL Medical Corporation20211—
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+8K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+8K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+8K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+8K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+8K181352Loop SystemSpry Health, Inc.201910—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+8K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+8K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+8K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+8K124041NBM-200MPOrsense, Ltd.20131—
+8K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+8K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K223721Masimo StorkMasimo Corporation20230—