Cleared Traditional

K962483 - MIDAS REX III MOTOR

K962483 is an FDA 510(k) clearance for MIDAS REX III MOTOR, manufactured by Midas Rex Pneumatic Tools, Inc.. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

FDA 510(k) Submission Details - K962483

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.

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.