Cleared Traditional

K060189 - PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

K060189 is an FDA 510(k) clearance for PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE), manufactured by Ives Eeg Solutions, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K060189 · Ives Eeg Solutions, Inc. · Neurology device
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May 2006
Decision
126d
Days
Class 2
Risk

K060189 is an FDA 510(k) clearance for the PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE). Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Ives Eeg Solutions, Inc. (Manotick, Ontario, CA). The FDA issued a Cleared decision on May 30, 2006 after a review of 126 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K060189

510(k) Number K060189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2006
Decision Date May 30, 2006
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 149d · This submission: 126d
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 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K060189.
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
K062996 · Axon Systems, Inc. · Jan 2007
SUBDERMAL WIRE ELECTRODE, MODEL SWE
K062880 · Ives Eeg Solutions, Inc. · Dec 2006
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
K050325 · Technomed Europe · May 2005
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
K050194 · Axon Systems, Inc. · Apr 2005
K060189 · PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
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