Cleared Traditional

K161566 - DMS Disposable Subdermal Needle Electrodes

K161566 is the FDA 510(k) clearance for DMS Disposable Subdermal Needle Electrodes by Daehan Medical Systems Co., Ltd.. It is a Class 2 Neurology device (product code GXZ) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K161566 · Daehan Medical Systems Co., Ltd. · Neurology device
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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.

View all Daehan Medical Systems Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · 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.

Regulatory Peers - GXZ Electrode, Needle

All 15
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K161566.
Guardian Needle Electrode
K200984 · Rhythmlink International, LLC · May 2020
Spes Medica Subdermal Needle Electrodes
K192603 · Spes Medica Srl · Nov 2019
PressOn Electrode Headset
K190801 · Rhythmlink International, LLC · Jul 2019
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
K110419 · Stryker Spine · Jul 2011
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007