GWM · Device, Monitoring, Intracranial Pressure

Neurology · 21 CFR 882.1620 · Class 2

Overview

Product CodeGWM
Device NameDevice, Monitoring, Intracranial Pressure
Regulation21 CFR 882.1620
Device ClassClass 2
Review PanelNeurology
3rd-Party ReviewableYes

Identification

An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 105)

Showing 20 most recent of 105 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaApr 10, 2026SESE
K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGAug 29, 2025SESE
K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.Jul 18, 2024SESE
K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationFeb 4, 2024SESE
K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.Oct 8, 2021SESE
K210993CereLink ICP MonitorIntegra Lifesciences Production CorporationApr 30, 2021SESE
K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelMedtronic, Inc.May 26, 2020SESE
K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage BagsMedtronic, Inc.Apr 9, 2020SESE
K200456Becker External Drainage and Monitoring SystemMedtronic, Inc.Mar 26, 2020SESE
K182073BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A.Oct 17, 2019SESE
K183406CereLink ICP Monitor, CereLink ICP Extension CableIntegra Lifesciences Corp.Jan 11, 2019SESE
K172209AURA ICP MONITORING SYSTEMBranchpoint Technologies, Inc.May 18, 2018SESE
K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc.Nov 8, 2017SESE
K171666MPR2 logO DATALOGGERRaumedic AGJul 6, 2017SESE
K162108Pressio 2 ICP Monitoring SystemSophysa SAApr 17, 2017SESE
K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc.Oct 20, 2016SESE
K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc.Aug 19, 2016SESE
K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARLJan 22, 2016SESE
K141869QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KITHemedex IncorporatedOct 10, 2014SESE
K133754INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTERIntegra LifeSciences CorporationMar 6, 2014SESE

Top Applicants

Innolitics

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