Cleared Traditional

K984035 - XK-95 HIGH SPEED MOTOR DRILL SYSTEM

K984035 is an FDA 510(k) clearance for XK-95 HIGH SPEED MOTOR DRILL SYSTEM, manufactured by Komet Medical. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K984035 · Komet Medical · Neurology device
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Jun 1999
Decision
203d
Days
Class 2
Risk

K984035 is an FDA 510(k) clearance for the XK-95 HIGH SPEED MOTOR DRILL SYSTEM. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Komet Medical (Atlanta, US). The FDA issued a Cleared decision on June 3, 1999 after a review of 203 days - an extended review 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: 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 Komet Medical devices

FDA 510(k) Submission Details - K984035

510(k) Number K984035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date June 03, 1999
Days to Decision 203 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
55d slower than avg
Panel avg: 148d · This submission: 203d
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 43
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K984035.
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · Stryker Instruments · Jan 2004
CRANIOCUT
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ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · The Anspach Effort, Inc. · Oct 2000
75K STAIGHT DRILL
K943541 · Stryker Corp. · May 1995
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K903664 · Micro-Aire Surgical Instruments, Inc. · Sep 1990
HUDSON CRANINAL BURRS
K875224 · Tri-Med, Inc. · Jan 1988