Cleared Traditional

K930229 - CLINICAL NEURO SYSTEMS CRANIAL DRILL

K930229 is an FDA 510(k) clearance for CLINICAL NEURO SYSTEMS CRANIAL DRILL, manufactured by Clinical Neuro Systems, LLC. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K930229 · Clinical Neuro Systems, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
56d
Days
Class 2
Risk

K930229 is an FDA 510(k) clearance for the CLINICAL NEURO SYSTEMS CRANIAL DRILL. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Clinical Neuro Systems, LLC (Santa Barbara, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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.

FDA 510(k) Submission Details - K930229

510(k) Number K930229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date March 16, 1993
Days to Decision 56 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 149d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 64
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K930229.
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K911812 · Acra Cut, Inc. · Sep 1991
ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
K911819 · Acra Cut, Inc. · Sep 1991
K930229 · CLINICAL NEURO SYSTEMS CRANIAL DRILL
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