510(k) Report

Devices descending from K914571

884 later devices reach Neurotrac II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K151354Cervello STIMBlackrock Neuromed20162—
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K131032Philips Suresigns CentralPhilips Medical Systems20131—
+6K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K112717Nuvasive Nvjjb SystemNuvasive, Inc.20120—
+6K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+6K112718Nuvasive NVM5 SystemNuvasive, Inc.201235—
+6K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K111520Ipc Powerease SystemMedtronic Xomed, Inc.20114182
+6K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K110696Neuro Check Device with IO-Flex WireBaxano, Inc.20110—
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+6K103686STAR 50 NLarsen & Toubro Limited20111—
+6K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+6K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+6K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+6K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+6K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+6K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+6K083719LNCS Oximetry SensorsMasimo Corporation20092—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K090172Star 55 Model 100Larsen & Toubro Limited20090—
+6K083622LNCS Oximetry SensorsMasimo Corporation20091—
+6K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+6K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+6K082685Galaxy 55Larsen & Toubro Limited20080—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+6K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+6K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+6K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+6K050128Vitalware VMSTelevital, Inc.20050—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K232035ImpalaAliveCor, Inc.20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K231625VitalDetectWellvii, Inc.20240—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+7K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+7K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+7K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+7K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K210637CD Horizon™ Spinal SystemMedtronic202134—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K192514Patient MonitorEdan Instruments, Inc.202061
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+7K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+7K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+7K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+7K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K161056Telemetry TransmitterEdan Instruments, Inc.201702
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—