GWM · Class II · 21 CFR 882.1620

FDA Product Code GWM: Device, Monitoring, Intracranial Pressure

Leading manufacturers include Johnson & Johnson Professionals, Inc., Medtronic, Inc. and Cordis Corp..

105
Total
105
Cleared
149d
Avg days
1978
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 197d 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 Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759
Aesculap, Inc.
Neurology · 204d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222
Johnson & Johnson Professionals, Inc.
Neurology · 88d
Cleared Jan 09, 1998
CODMAN INTRACRANIAL BOLT
K974088
Johnson & Johnson Professionals, Inc.
Neurology · 71d
Cleared Oct 26, 1995
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585
Johnson & Johnson Professionals, Inc.
Neurology · 346d
Cleared Mar 01, 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648
Cordis Corp.
Neurology · 379d
Cleared Jul 03, 1990
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823
Abbott Laboratories
Neurology · 592d
Cleared Dec 27, 1985
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657
Cordis Corp.
Neurology · 37d
Cleared Jan 03, 1978
CATHETER, INTRACRANIAL PRESS. MONITOR.
K772063
Cordis Corp.
Neurology · 62d

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 increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GWM Product Code

Recent submissions under GWM have taken an average of 197 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 →