Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1620](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1620) → GWM — Device, Monitoring, Intracranial Pressure # GWM · Device, Monitoring, Intracranial Pressure _Neurology · 21 CFR 882.1620 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM ## Overview - **Product Code:** GWM - **Device Name:** Device, Monitoring, Intracranial Pressure - **Regulation:** [21 CFR 882.1620](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1620) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## 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. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252241](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K252241.md) | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | Apr 10, 2026 | SESE | | [K250285](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K250285.md) | NEUROVENT-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); BOL | Raumedic AG | Aug 29, 2025 | SESE | | [K240821](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K240821.md) | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | Jul 18, 2024 | SESE | | [K232890](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K232890.md) | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra Lifesciences Production Corporation | Feb 4, 2024 | SESE | | [K201989](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K201989.md) | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | Oct 8, 2021 | SESE | | [K210993](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K210993.md) | CereLink ICP Monitor | Integra Lifesciences Production Corporation | Apr 30, 2021 | SESE | | [K201118](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K201118.md) | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | Medtronic, Inc. | May 26, 2020 | SESE | | [K200630](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K200630.md) | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Medtronic, Inc. | Apr 9, 2020 | SESE | | [K200456](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K200456.md) | Becker External Drainage and Monitoring System | Medtronic, Inc. | Mar 26, 2020 | SESE | | [K182073](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K182073.md) | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | Oct 17, 2019 | SESE | | [K183406](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K183406.md) | CereLink ICP Monitor, CereLink ICP Extension Cable | Integra Lifesciences Corp. | Jan 11, 2019 | SESE | | [K172209](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K172209.md) | AURA ICP MONITORING SYSTEM | Branchpoint Technologies, Inc. | May 18, 2018 | SESE | | [K173192](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K173192.md) | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | Codman & Shurtleff, Inc. | Nov 8, 2017 | SESE | | [K171666](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K171666.md) | MPR2 logO DATALOGGER | Raumedic AG | Jul 6, 2017 | SESE | | [K162108](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K162108.md) | Pressio 2 ICP Monitoring System | Sophysa SA | Apr 17, 2017 | SESE | | [K161010](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K161010.md) | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | Oct 20, 2016 | SESE | | [K153347](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K153347.md) | Codman 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 Kit | Codman & Shurtleff, Inc. | Aug 19, 2016 | SESE | | [K152670](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K152670.md) | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | Medos International SARL | Jan 22, 2016 | SESE | | [K141869](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K141869.md) | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | Hemedex Incorporated | Oct 10, 2014 | SESE | | [K133754](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM/K133754.md) | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | Integra LifeSciences Corporation | Mar 6, 2014 | SESE | ## Top Applicants - Codman & Shurtleff, Inc. — 9 clearances - Innerspace, Inc. — 7 clearances - Raumedic AG — 6 clearances - Integra LifeSciences Corporation — 5 clearances - Integra Neurosciences — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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