Cleared Traditional

K092477 - NeuroWave NeuroFAST MONITORING SYSTEM

K092477 is an FDA 510(k) clearance for NeuroWave NeuroFAST MONITORING SYSTEM, manufactured by Neurowave Systems, Inc.. The device is a Class 2 Neurology device with product code OMC cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K092477 · Neurowave Systems, Inc. · Neurology device
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Oct 2010
Decision
443d
Days
Class 2
Risk

K092477 is an FDA 510(k) clearance for the NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Neurowave Systems, Inc. (Cleveland Heights, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Neurowave Systems, Inc. devices

FDA 510(k) Submission Details - K092477

510(k) Number K092477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2009
Decision Date October 29, 2010
Days to Decision 443 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
295d slower than avg
Panel avg: 148d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMC Device Classification - Class 2, Special Controls

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 14
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