Cleared Traditional

K050194 - AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

K050194 is an FDA 510(k) clearance for AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES, manufactured by Axon Systems, Inc.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K050194 · Axon Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
89d
Days
Class 2
Risk

K050194 is an FDA 510(k) clearance for the AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 26, 2005 after a review of 89 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Axon Systems, Inc. devices

FDA 510(k) Submission Details - K050194

510(k) Number K050194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date April 26, 2005
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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 38
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K050194.
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
K060189 · Ives Eeg Solutions, Inc. · May 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
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
POLYMEDIC UPA NERVE STIMULATION NEEDLE
K990100 · Te ME NA S.A.R.L. · Aug 2000
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · Medtronic Xomed · Oct 1999