Cleared Traditional

K812284 - ZEE ELECTRODE-GEL

K812284 is the FDA 510(k) clearance for ZEE ELECTRODE-GEL by Zee Medical Products Co., Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K812284 · Zee Medical Products Co., Inc. · Neurology device
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Sep 1981
Decision
26d
Days
Class 2
Risk

K812284 is an FDA 510(k) clearance for the ZEE ELECTRODE-GEL. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Zee Medical Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Zee Medical Products Co., Inc. devices

Submission Details

510(k) Number K812284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1981
Decision Date September 08, 1981
Days to Decision 26 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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.