Cleared Traditional

Electrotherapy Electrodes (K250841) - FDA 510(k) Clearance

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

K250841 · Baisheng Medical Co., Ltd. · Neurology device
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Aug 2025
Decision
146d
Days
Class 2
Risk

K250841 is an FDA 510(k) clearance for the Electrotherapy Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Baisheng Medical Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on August 13, 2025 after a review of 146 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 Baisheng Medical Co., Ltd. devices

Submission Details

510(k) Number K250841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2025
Decision Date August 13, 2025
Days to Decision 146 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
2d faster than avg
Panel avg: 148d · This submission: 146d
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 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K250841.
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