Cleared Traditional

K112017 - RAUMEDIC ICP MONITORING SYSTEM (FDA 510(k) Clearance)

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

K112017 · Raumedic AG · Neurology device
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Oct 2011
Decision
89d
Days
Class 2
Risk

K112017 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 October 11, 2011 after a review of 89 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

Submission Details

510(k) Number K112017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2011
Decision Date October 11, 2011
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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 104
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K112017.
Pressio 3 Multi-parameter Neuromonitoring System
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CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation · Feb 2024
B4C System
K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2021
CereLink ICP Monitor
K210993 · Integra Lifesciences Production Corporation · Apr 2021