Cleared Traditional

K874735 - DANTEC 13L35/36/37 STIM. AND RECORDING ...

K874735 is the FDA 510(k) clearance for DANTEC 13L35/36/37 STIM. AND RECORDING ... by Dantec Electronics, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K874735 · Dantec Electronics, Inc. · Neurology device
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Jan 1988
Decision
65d
Days
Class 2
Risk

K874735 is an FDA 510(k) clearance for the DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 65 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 Dantec Electronics, Inc. devices

Submission Details

510(k) Number K874735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date January 22, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 148d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 147
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