Cleared Traditional

K962483 - MIDAS REX III MOTOR (FDA 510(k) Clearance)

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

K962483 · Midas Rex Pneumatic Tools, Inc. · Neurology device
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Nov 1996
Decision
146d
Days
Class 2
Risk

K962483 is an FDA 510(k) clearance for the MIDAS REX III MOTOR. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 146 days - within the typical 510(k) review window.

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: 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 Midas Rex Pneumatic Tools, Inc. devices

Submission Details

510(k) Number K962483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date November 19, 1996
Days to Decision 146 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
2d faster than avg
Panel avg: 148d · This submission: 146d
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.