Cleared Special

K030764 - Z-BOX

K030764 is an FDA 510(k) clearance for Z-BOX, manufactured by Z-Kat, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 44-day FDA review.

K030764 · Z-Kat, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
44d
Days
Class 2
Risk

K030764 is an FDA 510(k) clearance for the Z-BOX. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Z-Kat, Inc. (Hollywood, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 44 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030764

510(k) Number K030764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date April 24, 2003
Days to Decision 44 days
Submission Type Special
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
105d faster than avg
Panel avg: 149d · This submission: 44d
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 413
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K030764.
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K030764 · Z-BOX
Download PDF FDA Summary Z-Kat, Inc.