510(k) Report

Devices descending from K914571

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+7K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+7K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+7K130056Patient MonitorLd Technology, LLC20130—
+7K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+7K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+7K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+7K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+7K121264Triton Electric High Torque Handpiece and Software ModuleMedtronic Surgical Technologies201212—
+7K121424Expression Information PortalInvivo Corporation201224
+7K120631Patient MonitorAdvanced Instruments, Inc.20120—
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+7K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+7K103700Essential Mri Patient MonitorInvivo Corporation20110—
+7K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+7K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+7K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+7K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+7K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K260008Deterioration Index Version 2Epic Systems Corporation20260—
+8K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+8K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+8K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—
+8K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+8K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+8K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—