Cleared Traditional

K050702 - NEUROSYSTEMS 1TM MONITOR

K050702 is an FDA 510(k) clearance for NEUROSYSTEMS 1TM MONITOR, manufactured by Neurosystems, LLC. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K050702 · Neurosystems, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
60d
Days
Class 2
Risk

K050702 is an FDA 510(k) clearance for the NEUROSYSTEMS 1TM MONITOR. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Neurosystems, LLC (Woodstock, US). The FDA issued a Cleared decision on May 17, 2005 after a review of 60 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 Neurosystems, LLC devices

FDA 510(k) Submission Details - K050702

510(k) Number K050702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2005
Decision Date May 17, 2005
Days to Decision 60 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
88d faster than avg
Panel avg: 148d · This submission: 60d
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
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K050702.
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K040235 · Integra LifeSciences Corporation · Apr 2004
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
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