Cleared Traditional

K103206 - RAUMEDIC- ICP-MONITORING SYSTEM

K103206 is an FDA 510(k) clearance for RAUMEDIC- ICP-MONITORING SYSTEM, manufactured by Raumedic AG. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K103206 · Raumedic AG · Neurology device
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Mar 2011
Decision
123d
Days
Class 2
Risk

K103206 is an FDA 510(k) clearance for the RAUMEDIC- ICP-MONITORING SYSTEM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Raumedic AG (Helmbrechts, DE). The FDA issued a Cleared decision on March 4, 2011 after a review of 123 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 Raumedic AG devices

FDA 510(k) Submission Details - K103206

510(k) Number K103206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date March 04, 2011
Days to Decision 123 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 42
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K103206.
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
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