Cleared Traditional

K180247 - DAEHAN Adhesive Surface Electrodes

K180247 is an FDA 510(k) clearance for DAEHAN Adhesive Surface Electrodes, manufactured by Daehan Medical Systems Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K180247 · Daehan Medical Systems Co., Ltd. · Neurology device
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Nov 2018
Decision
276d
Days
Class 2
Risk

K180247 is an FDA 510(k) clearance for the DAEHAN Adhesive Surface Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Daehan Medical Systems Co., Ltd. (Siheung-City, KR). The FDA issued a Cleared decision on November 1, 2018 after a review of 276 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.

View all Daehan Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K180247

510(k) Number K180247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date November 01, 2018
Days to Decision 276 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
128d slower than avg
Panel avg: 148d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 290
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