Cleared Traditional

K020567 - AKUPORT M1

K020567 is an FDA 510(k) clearance for AKUPORT M1, manufactured by Vibrant Health. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K020567 · Vibrant Health · Neurology device
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May 2002
Decision
71d
Days
Class 2
Risk

K020567 is an FDA 510(k) clearance for the AKUPORT M1. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Vibrant Health (Beoeil, Quebec, CA). The FDA issued a Cleared decision on May 2, 2002 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - 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.

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FDA 510(k) Submission Details - K020567

510(k) Number K020567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2002
Decision Date May 02, 2002
Days to Decision 71 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
77d faster than avg
Panel avg: 148d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZO Device Classification - Class 2, Special Controls

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
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.