Cleared Traditional

K081475 - ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM

K081475 is an FDA 510(k) clearance for ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K081475 · Medtronic Xomed, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2008
Decision
143d
Days
Class 2
Risk

K081475 is an FDA 510(k) clearance for the ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRAT.... Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 17, 2008 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K081475

510(k) Number K081475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date October 17, 2008
Days to Decision 143 days
Submission Type Traditional
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
5d faster than avg
Panel avg: 148d · This submission: 143d
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 41
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K081475.
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K062842 · Walter Lorenz Surgical, Inc. · Dec 2006
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