Cleared Traditional

K022914 - RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

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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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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 149d · 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 43
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K022914.
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
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
K023472 · Class A Enterprises, Inc. · Mar 2003
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
K020910 · The Electrode Store, Inc. · Jul 2002
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
K021118 · Class A Ent. · May 2002
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019 · Nicolet Biomedical, Inc. · Mar 2001