Cleared Special

K183406 - CereLink ICP Monitor

K183406 is the FDA 510(k) clearance for CereLink ICP Monitor by Integra Lifesciences Corp.. It is a Class 2 Neurology device (product code GWM) cleared through the Special 510(k) pathway after a 32-day FDA review.

K183406 · Integra Lifesciences Corp. · Neurology device
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Jan 2019
Decision
32d
Days
Class 2
Risk

K183406 is an FDA 510(k) clearance for the CereLink ICP Monitor, CereLink ICP Extension Cable. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra Lifesciences Corp. devices

Submission Details

510(k) Number K183406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2018
Decision Date January 11, 2019
Days to Decision 32 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 148d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 37
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K183406.
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
K200630 · Medtronic, Inc. · Apr 2020
Becker External Drainage and Monitoring System
K200456 · Medtronic, Inc. · Mar 2020
BcSs-PICNI-2000 Sensor
K182073 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2019
AURA ICP MONITORING SYSTEM
K172209 · Branchpoint Technologies, Inc. · May 2018
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. · Nov 2017
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. · Aug 2016