Cleared Traditional

K142159 - DISPOSABLE PRE-GELLED SURFACE ELECTRODE

K142159 is an FDA 510(k) clearance for DISPOSABLE PRE-GELLED SURFACE ELECTRODE, manufactured by Rochester Electro Medical, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K142159 · Rochester Electro Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
301d
Days
Class 2
Risk

K142159 is an FDA 510(k) clearance for the DISPOSABLE PRE-GELLED SURFACE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Rochester Electro Medical, Inc. (Odessa, US). The FDA issued a Cleared decision on June 3, 2015 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K142159

510(k) Number K142159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date June 03, 2015
Days to Decision 301 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 149d · This submission: 301d
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 358
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K142159.
Neon EEG
K151576 · Incereb, Ltd. · Sep 2015
Zekang Self-adhesive Electrode
K150971 · Jiangsu Zekang Medical Technology Co., Ltd. · Aug 2015
Philips Self-Adhesive Electrodes
K151033 · Philips Consumer Lifestyle · Jul 2015
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES)
K143506 · Covidien · Apr 2015
ASCEND ELECTRODE
K140586 · Neurometrix, Inc. · Nov 2014
CUTANEOUS ELECTRODES
K142099 · Bio Protech, Inc. · Nov 2014