Cleared Traditional

K895460 - CONCENTRIC ELECTRODE TYPE #13R01, 13R02

K895460 is an FDA 510(k) clearance for CONCENTRIC ELECTRODE TYPE #13R01, manufactured by Dantec Electronics, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K895460 · Dantec Electronics, Inc. · Neurology device
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Jun 1990
Decision
285d
Days
Class 2
Risk

K895460 is an FDA 510(k) clearance for the CONCENTRIC ELECTRODE TYPE #13R01, 13R02. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on June 18, 1990 after a review of 285 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dantec Electronics, Inc. devices

FDA 510(k) Submission Details - K895460

510(k) Number K895460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date June 18, 1990
Days to Decision 285 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 148d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

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

All 36
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K895460.
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DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
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DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874 · Dantec Medical, Inc. · Jun 1990
EMG ELECTRODES AND EXTENSION CORDS
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K854664 · Nihon Kohden America, Inc. · Aug 1986