Midas Rex III Motor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K962483 ↗

FDA Product Code

HBB

Device Class

Class II

Regulation

21 CFR Part 882.4370

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Midas Rex Drill Attachments & Twist Drills

  Class I

  FDA 510(k) K954076 Active Cleared 18 Oct 1995

• Midas Rex Motors (Midas I, II & Convertible Models)

  Class I

  FDA 510(k) K952300 Active Cleared 26 May 1995

• Midas Rex Telescoping System

  Class I

  FDA 510(k) K953433 Active Cleared 15 Sep 1995

• Midas Rex Operating Room Vise

  Not classified

  FDA 510(k) K854123 Active Cleared 13 Nov 1985

• Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools

  Class I

  FDA 510(k) K953432 Active Cleared 14 Sep 1995

• Midas Rex Motors, (Midas I, Midas II & Convertible Models)

  Class II

  FDA 510(k) K953434 Active Cleared 16 May 1996

See all devices from Midas Rex Pneumatic Tools, Inc. →

• Is the Midas Rex III Motor designed for single-use or can it be reused in multiple procedures?

  The Midas Rex III Motor is explicitly described as a reusable medical instrument. Since it is classified under FDA Class II and cleared via a 510(k) pathway, its design and intended use align with instruments meant for repeated clinical use, provided proper cleaning, maintenance, and sterilization protocols are followed as per manufacturer guidelines.

• What operating pressures and speeds does the Midas Rex III Motor support, and what is the recommended setting for most surgical applications?

  The device operates within a pressure range of 20–150 psi (2–10 bar) and offers variable speeds for precise control. The manufacturer recommends using 100 psi (6.9 bar) as the standard operating pressure for optimal performance in surgical applications, particularly in neurosurgical and otolaryngological procedures.

• How is the Midas Rex III Motor regulated, and what does its FDA clearance indicate about its intended use?

  The Midas Rex III Motor is cleared via the FDA’s Traditional 510(k) pathway (K962483) and classified under FDA Class II (product code HBB). This clearance indicates the device is substantially equivalent to a legally marketed predecessor and is intended for surgical drilling applications, specifically in neurosurgery and otolaryngology, where controlled rotational power is required.

• Are there any specific storage requirements or considerations for the Midas Rex III Motor?

  While the provided data does not explicitly detail storage conditions, as a reusable pneumatic surgical motor, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper maintenance, including lubrication and inspection, is critical to ensure reliable performance and longevity, especially given its use in sterile surgical fields.

• Does the Midas Rex III Motor have any special compatibility or safety notes for use in clinical settings?

  The regulatory data does not mention sterility specifications or MRI safety certifications, meaning the device is not pre-sterilized or explicitly labeled for MRI-compatible use. Clinicians should follow standard surgical instrument protocols for cleaning, sterilization, and handling, and ensure compatibility with their facility’s pneumatic systems before use.