Cleared Traditional

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (K932059) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932059 · Dantec Medical, Inc. · Neurology device
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Oct 1994
Decision
523d
Days
Class 2
Risk

K932059 is an FDA 510(k) clearance for the NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 523 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Dantec Medical, Inc. devices

Submission Details

510(k) Number K932059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1993
Decision Date October 04, 1994
Days to Decision 523 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
375d slower than avg
Panel avg: 148d · This submission: 523d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

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