Cleared Traditional

K013930 - NEUROSENSOR

K013930 is an FDA 510(k) clearance for NEUROSENSOR, manufactured by Novus Monitoring, Ltd.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K013930 · Novus Monitoring, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
84d
Days
Class 2
Risk

K013930 is an FDA 510(k) clearance for the NEUROSENSOR. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Novus Monitoring, Ltd. (United Kingdom, GB). The FDA issued a Cleared decision on February 20, 2002 after a review of 84 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 Novus Monitoring, Ltd. devices

FDA 510(k) Submission Details - K013930

510(k) Number K013930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2001
Decision Date February 20, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 148d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 58
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