Cleared Traditional

K161566 - DMS Disposable Subdermal Needle Electrodes (FDA 510(k) Clearance)

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

K161566 · Daehan Medical Systems Co., Ltd. · Neurology device
Dec 2016
Decision
198d
Days
Class 2
Risk

K161566 is an FDA 510(k) clearance for the DMS Disposable Subdermal Needle Electrodes. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Daehan Medical Systems Co., Ltd. (Siheung-City, KR). The FDA issued a Cleared decision on December 21, 2016 after a review of 198 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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 K161566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2016
Decision Date December 21, 2016
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 162d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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.