Cleared Traditional

K991625 - KOMET XK-95 PERFORATOR MOTOR (MI-102)

K991625 is an FDA 510(k) clearance for KOMET XK-95 PERFORATOR MOTOR (MI-102), manufactured by Komet Medical. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K991625 · Komet Medical · Neurology device
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Jul 1999
Decision
80d
Days
Class 2
Risk

K991625 is an FDA 510(k) clearance for the KOMET XK-95 PERFORATOR MOTOR (MI-102). Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Komet Medical (Savannah, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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.

View all Komet Medical devices

FDA 510(k) Submission Details - K991625

510(k) Number K991625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1999
Decision Date July 30, 1999
Days to Decision 80 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
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 - HBB Motor, Drill, Pneumatic

All 21
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K991625.
CRANIAL DRILL
K000195 · Image-Guided Neurologics, Inc. · Apr 2000
SODEM PERFORATOR DRIVE
K993851 · Sodemsystems · Dec 1999
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
K994175 · Sodemsystems · Dec 1999
TRITON HUDSON CHUCK ATTACHMENT
K983092 · Mednext, Inc. · Nov 1998
AESCULAP HILAN MOTOR SYSTEM
K980686 · Aesculap, Inc. · Sep 1998
MIDAS REX MOTOR
K972289 · Midas Rex Pneumatic Tools, Inc. · Sep 1997