Cleared Traditional

SM Electrodes (K183154) - FDA 510(k) Clearance

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

K183154 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
132d
Days
Class 2
Risk

K183154 is an FDA 510(k) clearance for the SM Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on March 26, 2019 after a review of 132 days - within the typical 510(k) review window.

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. 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 Hong Qiangxing (Shenzhen) Electronics Limited devices

Submission Details

510(k) Number K183154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2018
Decision Date March 26, 2019
Days to Decision 132 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
16d faster than avg
Panel avg: 148d · This submission: 132d
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 Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXY Electrode, Cutaneous

All 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K183154.
COMPLETE CONTROL System Gen2
K191083 · Coapt, LLC · May 2019
Dome Electrode
K190416 · Coapt, LLC · Apr 2019
DAEHAN Disposable CUP Electrodes
K180232 · Daehan Medical Systems Co., Ltd. · Apr 2019
DL Self-adhesive Electrode
K182111 · Shaoxing DL Healthcare Co., Ltd. · Jan 2019
Espire Elbow Pro, Espire Elbow Hybrid
K182757 · College Park Industries, Inc. · Nov 2018
DAEHAN Adhesive Surface Electrodes
K180247 · Daehan Medical Systems Co., Ltd. · Nov 2018