Cleared Abbreviated

XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 (K052111) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052111 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
13d
Days
Class 2
Risk

K052111 is an FDA 510(k) clearance for the XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville, CA). The FDA issued a Cleared decision on August 17, 2005 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Excel Tech. , Ltd. devices

Submission Details

510(k) Number K052111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2005
Decision Date August 17, 2005
Days to Decision 13 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 148d · This submission: 13d
Pathway characteristics
Standards-based clearance path.

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 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K052111.
Disposable Subdermal Needle Electrode, Corkscrew
K241045 · Technomed Europe · Dec 2024
Medical Disposable Sterile Needle Electrode
K232581 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023
Phantom XL Insulated Dilators
K231691 · TeDan Surgical Innovations, Inc. · Jun 2023
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