Cleared Traditional

K240668 - Amydi-med Disposable Non-invasive EEG electrodes (FDA 510(k) Clearance)

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

K240668 · Shenzhen Amydi-Med Electrics Tech Co., Ltd. · Neurology device
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Mar 2024
Decision
11d
Days
Class 2
Risk

K240668 is an FDA 510(k) clearance for the Amydi-med Disposable Non-invasive EEG electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shenzhen Amydi-Med Electrics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 19, 2024 after a review of 11 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Amydi-Med Electrics Tech Co., Ltd. devices

Submission Details

510(k) Number K240668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2024
Decision Date March 19, 2024
Days to Decision 11 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 148d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 433
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