Cleared Traditional

RAUMEDIC-PTO-MONITORING-SYSTEM (K130529) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130529 · Raumedic AG · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2013
Decision
238d
Days
Class 2
Risk

K130529 is an FDA 510(k) clearance for the RAUMEDIC-PTO-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 October 25, 2013 after a review of 238 days - an extended review cycle.

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

Submission Details

510(k) Number K130529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date October 25, 2013
Days to Decision 238 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
90d slower than avg
Panel avg: 148d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K130529.
AURA ICP MONITORING SYSTEM
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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