Cleared Traditional

K231164 - Conductive carbon film electrode

K231164 is an FDA 510(k) clearance for Conductive carbon film electrode, manufactured by Guangzhou Xinbo Electronic Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K231164 · Guangzhou Xinbo Electronic Co., Ltd. · Neurology device
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Aug 2023
Decision
106d
Days
Class 2
Risk

K231164 is an FDA 510(k) clearance for the Conductive carbon film electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Guangzhou Xinbo Electronic Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 9, 2023 after a review of 106 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 Guangzhou Xinbo Electronic Co., Ltd. devices

FDA 510(k) Submission Details - K231164

510(k) Number K231164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2023
Decision Date August 09, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 148d · This submission: 106d
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 184
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