Cleared Traditional

K120342 - EMG RECORDING ELECTRODE ASSEMBLY

K120342 is an FDA 510(k) clearance for EMG RECORDING ELECTRODE ASSEMBLY, manufactured by Rhythmlink International, LLC. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K120342 · Rhythmlink International, LLC · Neurology device
Download Printable Device Report (PDF)
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Jun 2012
Decision
140d
Days
Class 2
Risk

K120342 is an FDA 510(k) clearance for the EMG RECORDING ELECTRODE ASSEMBLY. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on June 22, 2012 after a review of 140 days - within the typical 510(k) review window.

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 Rhythmlink International, LLC devices

FDA 510(k) Submission Details - K120342

510(k) Number K120342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2012
Decision Date June 22, 2012
Days to Decision 140 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
8d faster than avg
Panel avg: 148d · This submission: 140d
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 9
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