Cleared Special

K013396 - ALPHA DRIVE SYSTEM

K013396 is an FDA 510(k) clearance for ALPHA DRIVE SYSTEM, manufactured by Alpha Omega , Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 296-day FDA review.

K013396 · Alpha Omega , Ltd. · Neurology device
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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

FDA 510(k) Submission Details - K013396

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.

HAW Device Classification - Class 2, Special Controls

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 292
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