Cleared Traditional

K130529 - RAUMEDIC-PTO-MONITORING-SYSTEM

K130529 is an FDA 510(k) clearance for RAUMEDIC-PTO-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 238-day FDA review.

K130529 · Raumedic AG · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K130529

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.

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
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