Cleared Traditional

K220448 - Disposable Non-invasive EEG Sensor (FDA 510(k) Clearance)

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

K220448 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Neurology device
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Jan 2023
Decision
337d
Days
Class 2
Risk

K220448 is an FDA 510(k) clearance for the Disposable Non-invasive EEG Sensor. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 19, 2023 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shenzhen Med-Link Electronics Tech Co., Ltd. devices

Submission Details

510(k) Number K220448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2022
Decision Date January 19, 2023
Days to Decision 337 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 148d · This submission: 337d
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
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K220448.
Tutamen Self Adhesive Electrodes
K252439 · Dongguan Tutamen Metalwork Co., Ltd. · May 2026
myosmart. (13E522)
K253256 · Otto Bock Healthcare Products GmbH · Apr 2026
Ceribell Brain Monitor Headband
K260363 · Ceribell, Inc. · Apr 2026
Remote Wave Electrode (AE03-50)
K260453 · Bionit Labs Srl · Mar 2026
Ceribell Instant EEG Headset
K254033 · Ceribell, Inc. · Feb 2026
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · Ceribell, Inc. · Oct 2025