Cleared Traditional

K840591 - ELECTRODE PLACEMENT SLEEVE

K840591 is an FDA 510(k) clearance for ELECTRODE PLACEMENT SLEEVE, manufactured by Bio-Stimu Trend Corp.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K840591 · Bio-Stimu Trend Corp. · Neurology device
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Mar 1984
Decision
43d
Days
Class 2
Risk

K840591 is an FDA 510(k) clearance for the ELECTRODE PLACEMENT SLEEVE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bio-Stimu Trend Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Bio-Stimu Trend Corp. devices

FDA 510(k) Submission Details - K840591

510(k) Number K840591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1984
Decision Date March 23, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 148d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 319
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K840591.
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