Cleared Traditional

K022914 - RHYTHMLINK INTERNATIONAL SUBDERMAL NEED...

K022914 is an FDA 510(k) clearance for RHYTHMLINK INTERNATIONAL SUBDERMAL NEED..., manufactured by Rhythmlink International, LLC. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K022914 · Rhythmlink International, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
108d
Days
Class 2
Risk

K022914 is an FDA 510(k) clearance for the RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Rhythmlink International, LLC (Cayce, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 108 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.

View all Rhythmlink International, LLC devices

FDA 510(k) Submission Details - K022914

510(k) Number K022914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date December 20, 2002
Days to Decision 108 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
40d faster than avg
Panel avg: 148d · This submission: 108d
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 17
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K022914.
NERVE MONITORING CABLE
K073229 · Pioneer Surgical Technology · Jun 2008
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · Ambu A/S · May 2007
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314 · Dantec Medical, Inc. · Mar 1996
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc. · Apr 1994