Cleared Traditional

K182111 - DL Self-adhesive Electrode (FDA 510(k) Clearance)

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

K182111 · Shaoxing DL Healthcare Co., Ltd. · Neurology device
Jan 2019
Decision
164d
Days
Class 2
Risk

K182111 is an FDA 510(k) clearance for the DL Self-adhesive Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Shaoxing DL Healthcare Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on January 17, 2019 after a review of 164 days - an extended review 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: 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.

Submission Details

510(k) Number K182111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2018
Decision Date January 17, 2019
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 162d · This submission: 164d
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

Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K182111.
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