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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 149d · 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 Consultant

Tuv Sud America, Inc.
NORBERT STUIBER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 84
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K103206.
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
K113088 · Innerspace, Inc. · May 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252 · Raumedic AG · Apr 2012
RAUMEDIC ICP MONITORING SYSTEM
K112017 · Raumedic AG · Oct 2011
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K102077 · Cma Microdialysis AB · Jan 2011
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · Integra LifeSciences Corporation · Dec 2010
SENSOMETRICS SOFTWARE
K101133 · Dpcom AS · Nov 2010