Cleared Traditional

K051830 - NEURODRIVE SYSTEM

K051830 is an FDA 510(k) clearance for NEURODRIVE SYSTEM, manufactured by Alpha Omega , Ltd.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K051830 · Alpha Omega , Ltd. · Neurology device
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Sep 2005
Decision
72d
Days
Class 2
Risk

K051830 is an FDA 510(k) clearance for the NEURODRIVE SYSTEM. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpha Omega , Ltd. (Nazareth Illit, IL). The FDA issued a Cleared decision on September 16, 2005 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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 Alpha Omega , Ltd. devices

FDA 510(k) Submission Details - K051830

510(k) Number K051830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2005
Decision Date September 16, 2005
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 148d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 35
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K051830.
Anchor Bolt (as an accessory to Depth Electrodes)
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NeuroNav System, NeuroSmart System
K172042 · Alpha Omega Engineering , Ltd. · Feb 2018
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358 · Ad-Tech Medical Instrument Corp · May 2006
MACRO-MICRO DEPTH ELECTRODE
K041604 · Ad-Tech Medical Instrument Corp · Aug 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004
MICROTARGETING ELECTRODE
K991522 · FHC, Inc. · Aug 2000