GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Codman & Shurtleff, Inc., Integra LifeSciences Corporation and Raumedic AG.

105
Total
105
Cleared
149d
Avg days
1978
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 239d recently vs 147d historically

FDA 510(k) Cleared Device, Monitoring, Intracranial Pressure Devices (Product Code GWM)

105 devices
1–24 of 105
Cleared Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
K252241
Sophysa
Neurology · 267d
Cleared Aug 29, 2025
NEUROVENT-P (092946-003)
K250285
Raumedic AG
Neurology · 210d
Cleared Jul 18, 2024
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821
Braincare Desenvolvimento E Inova??o Tecnol?gica S.A.
Neurology · 115d
Cleared Feb 04, 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890
Integra Lifesciences Production Corporation
Neurology · 139d
Cleared Oct 08, 2021
B4C System
K201989
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Neurology · 448d
Cleared Apr 30, 2021
CereLink ICP Monitor
K210993
Integra Lifesciences Production Corporation
Neurology · 28d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
K201118
Medtronic, Inc.
Neurology · 29d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K200630
Medtronic, Inc.
Neurology · 30d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456
Medtronic, Inc.
Neurology · 30d
Cleared Oct 17, 2019
BcSs-PICNI-2000 Sensor
K182073
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Neurology · 442d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406
Integra Lifesciences Corp.
Neurology · 32d
Cleared May 18, 2018
AURA ICP MONITORING SYSTEM
K172209
Branchpoint Technologies, Inc.
Neurology · 298d
Cleared Nov 08, 2017
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
K173192
Codman & Shurtleff, Inc.
Neurology · 37d
Cleared Jul 06, 2017
MPR2 logO DATALOGGER
K171666
Raumedic AG
Neurology · 31d
Cleared Apr 17, 2017
Pressio 2 ICP Monitoring System
K162108
Sophysa SA
Neurology · 262d
Cleared Oct 20, 2016
HICP200 Patient/Monitor Interconnect Cable
K161010
Innerspace Neuro Solutions, Inc.
Neurology · 192d
Cleared Aug 19, 2016
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
K153347
Codman & Shurtleff, Inc.
Neurology · 273d
Cleared Jan 22, 2016
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
K152670
Medos International SARL
Neurology · 127d
Cleared Oct 10, 2014
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
K141869
Hemedex Incorporated
Neurology · 91d
Cleared Mar 06, 2014
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K133754
Integra LifeSciences Corporation
Neurology · 87d
Cleared Oct 25, 2013
RAUMEDIC-PTO-MONITORING-SYSTEM
K130529
Raumedic AG
Neurology · 238d
Cleared Aug 30, 2013
INTEGRA LICOX PTO2 MONITOR
K131184
Integra Lifesciences Corp.
Neurology · 127d
Cleared Sep 10, 2012
INTEGRA CAMINO ICP MONITOR
K121573
Intrgra Lifesciences Corporation
Neurology · 104d
Cleared Jul 20, 2012
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
K121159
Integra Lifescience Corportation
Neurology · 95d

About Product Code GWM - Regulatory Context

510(k) Submission Activity

105 total 510(k) submissions under product code GWM since 1978, with 105 receiving FDA clearance (average review time: 149 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - GWM Product Code

Recent submissions under GWM have taken an average of 239 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.

GWM devices are reviewed by the Neurology panel. Browse all Neurology devices →