Cleared Traditional

NEURO-AIDE (K942926) - FDA 510(k) Clearance

Class I Neurology device.

K942926 · Burke Neutech, Inc. · Neurology device
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Aug 1994
Decision
42d
Days
Class 1
Risk

K942926 is an FDA 510(k) clearance for the NEURO-AIDE. Classified as Pinwheel (product code GWY), Class I - General Controls.

Submitted by Burke Neutech, Inc. (Largo, US). The FDA issued a Cleared decision on August 3, 1994 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1750 - 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 Burke Neutech, Inc. devices

Submission Details

510(k) Number K942926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1994
Decision Date August 03, 1994
Days to Decision 42 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
106d faster than avg
Panel avg: 148d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWY Pinwheel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.