Cleared Traditional

K161566 - DMS Disposable Subdermal Needle Electrodes

K161566 is an FDA 510(k) clearance for DMS Disposable Subdermal Needle Electrodes, manufactured by Daehan Medical Systems Co., Ltd.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K161566

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
Combination Product No
PCCP Authorized No
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.

GXZ Device Classification - Class 2, Special Controls

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 33
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
E-Shield Multi-paried Subdermal Needle Electrodes
K142470 · Neuroinvent, Inc. · Nov 2014
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
K140200 · Neuroinvent, Inc. · Jul 2014
MR CONDITIONAL PRESSON ELECTRODE
K130220 · Rhythmlink International, LLC · Jul 2013