Cleared Special

ALPHA DRIVE SYSTEM (K013396) - FDA 510(k) Clearance

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

K013396 · Alpha Omega , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
296d
Days
Class 2
Risk

K013396 is an FDA 510(k) clearance for the ALPHA DRIVE SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Alpha Omega , Ltd. (Nazareth Illit, IL). The FDA issued a Cleared decision on August 7, 2002 after a review of 296 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alpha Omega , Ltd. devices

Submission Details

510(k) Number K013396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date August 07, 2002
Days to Decision 296 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 148d · This submission: 296d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 422
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K013396.
Zeta Navigation System
K253663 · Zeta Surgical, Inc. · May 2026
Stealth AXiS Cranial clinical application
K253379 · Medtronic Navigation, Inc. · Mar 2026
NeuroAlign software
K231897 · Medivis, Inc. · Oct 2025
SOLOPASS 2.0 System
K251317 · Intravent Medical Partners · Sep 2025
Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025