Cleared Traditional

K152670 - DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

K152670 is an FDA 510(k) clearance for DirectLink ICP Module, manufactured by Medos International SARL. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K152670 · Medos International SARL · Neurology device
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Jan 2016
Decision
127d
Days
Class 2
Risk

K152670 is an FDA 510(k) clearance for the DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interf.... Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on January 22, 2016 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medos International SARL devices

FDA 510(k) Submission Details - K152670

510(k) Number K152670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2015
Decision Date January 22, 2016
Days to Decision 127 days
Submission Type Traditional
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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K152670.
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
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K133754 · Integra LifeSciences Corporation · Mar 2014
INTEGRA LICOX PTO2 MONITOR
K131184 · Integra Lifesciences Corp. · Aug 2013
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · Integra LifeSciences Corporation · Dec 2010