Cleared Traditional

DEI MODEL 20 EEG (K961718) - FDA 510(k) Clearance

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

K961718 · Discovery Engineering Intl., Inc. · Neurology device
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Aug 1996
Decision
117d
Days
Class 2
Risk

K961718 is an FDA 510(k) clearance for the DEI MODEL 20 EEG. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Discovery Engineering Intl., Inc. (Topeka, US). The FDA issued a Cleared decision on August 27, 1996 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Discovery Engineering Intl., Inc. devices

Submission Details

510(k) Number K961718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date August 27, 1996
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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.