Cleared Traditional

K883557 - NEUROWAVE SYSTEM 2

K883557 is the FDA 510(k) clearance for NEUROWAVE SYSTEM 2 by Durden Enterprises, Inc.. It is a Class 2 Neurology device (product code GWQ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K883557 · Durden Enterprises, Inc. · Neurology device
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Dec 1988
Decision
119d
Days
Class 2
Risk

K883557 is an FDA 510(k) clearance for the NEUROWAVE SYSTEM 2. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Durden Enterprises, Inc. (Auburn, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Durden Enterprises, Inc. devices

Submission Details

510(k) Number K883557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1988
Decision Date December 16, 1988
Days to Decision 119 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 148d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWQ Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 94
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K883557.
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