510(k) Report

Devices descending from K974088

34 later devices reach Codman Intracranial Bolt through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062584Pressio Icp Monitoring SystemSophysa SA200782
+1K032337Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated20031—
+1K013930NeurosensorNovus Monitoring, Ltd.200222—
+2K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+2K141869Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated20140—
+2K112017Raumedic Icp Monitoring SystemRaumedic AG20116—
+2K103206Raumedic- Icp-Monitoring SystemRaumedic AG20117—
+2K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+2K050720Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…Integra Neurosciences200511
+2K042728Camino Slim-Line Intracranial Monitoring SystemNovus Monitoring, Ltd.20041—
+3K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+3K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+3K172209Aura Icp Monitoring SystemBranchpoint Technologies, Inc.20180—
+3K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+3K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG20125—
+3K101133Sensometrics SoftwareDpcom AS20100—
+3K071505Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra LifeSciences Corporation200701
+3K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+4K171666MPR2 logO DATALOGGERRaumedic AG20170—
+4K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+5K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+5K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+5K192572CNS EnvisionMoberg Research, Inc.20190—
+5K173366NicoletOneNatus Neurology Incorporated20183—
+5K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+6K251881HippoMind (v1.0)Hippoclinic20250—
+6K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+6K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+6K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+7K213299Wireless EEG SystemPascall Systems, Inc.20222—
+7K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+7K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+8K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+8K240593VEEGix EEG SystemNeuroServo, Inc.20240—