Cleared Traditional

K152670 - DirectLink ICP Module

K152670 is the FDA 510(k) clearance for DirectLink ICP Module by Medos International SARL. It is a Class 2 Neurology device (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

Submission Details

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.

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 29
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
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc. · Jun 2001
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc. · Oct 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · Johnson & Johnson Professionals, Inc. · Jul 1999