Cleared Traditional

K120252 - RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM

K120252 is an FDA 510(k) clearance for RAUMEDIC-ICP-TEMP-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 75-day FDA review.

K120252 · Raumedic AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
75d
Days
Class 2
Risk

K120252 is an FDA 510(k) clearance for the RAUMEDIC-ICP-TEMP-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 April 11, 2012 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Raumedic AG devices

FDA 510(k) Submission Details - K120252

510(k) Number K120252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date April 11, 2012
Days to Decision 75 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
74d faster than avg
Panel avg: 149d · This submission: 75d
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.
OLAF TEICHERT

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 K120252.
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