Cleared Traditional

K020069 - MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020069 · Medtronic Midas Rex · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
68d
Days
Class 2
Risk

K020069 is an FDA 510(k) clearance for the MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTE.... Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Medtronic Midas Rex (Fort Worth, US). The FDA issued a Cleared decision on March 18, 2002 after a review of 68 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 Medtronic Midas Rex devices

Submission Details

510(k) Number K020069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2002
Decision Date March 18, 2002
Days to Decision 68 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 148d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.