Cleared Traditional

K231164 - Conductive carbon film electrode (FDA 510(k) Clearance)

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

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

Submission Details

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.

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 Peers - GXY Electrode, Cutaneous

All 433
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