510(k) Report

510(k) · Cleared

Cleared

Midas Rex Iii Motor

K962483510(k) TraditionalCleared Nov 19, 1996146-day reviewClass II21 CFR 882.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Midas Rex Pneumatic Tools, Inc. · HBB Motor, Drill, Pneumatic

Cleared on Nov 19, 1996 as substantially equivalent to K953434 (Midas Rex Pneumatic Tools, Inc., 1996) and 4 other predicates after a 146-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided
Nov 19, 1996
Review
146 days
Class
Class II
Product code
HBB
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K952300 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 3 other ancestors1997: 1 descendant clearedK952300 · Midas Rex Motors (Midas I, II & Convertible Models) · Midas Rex Pneumatic Tools, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K952300 · Midas Rex Motors (Midas I, II & Convertible Models) · Midas Rex Pneumatic Tools, Inc. · 19950
  1. Root · 1 generation backK952300 Midas Rex Motors (Midas I, II & Convertible Models)Midas Rex Pneumatic Tools, Inc. · 1995
  2. This deviceK962483 Midas Rex Iii MotorMidas Rex Pneumatic Tools, Inc. · 1996
  3. Descendant · cites it directly · 0 of its ownK970965 Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970965Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K952300Midas Rex Motors (Midas I, II & Convertible Models)Midas Rex Pneumatic Tools, Inc.1995—
0 (this device)K962483Midas Rex Iii MotorMidas Rex Pneumatic Tools, Inc.1996—
+1K970965Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199530
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K962483, 1995–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HBB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HBB device

  1. #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K953434Midas Rex Motors, (Midas I, Midas II & Convertible Models)
Summary page 1
…831-4181 Michael Fowler Director Regulatory Affairs Midas Rex Motor (Midas IIT) Pneumatic Cranial Drill Motor Class I Midas Rex Motors, Midas (I, I, & Convertible) K953434 Class I Midas (1, IT, & Convertible) K952300 Class I Whirl Wind ™ ( Pre-1976) Midas GS and GS20 Surgical Tool System K952463 Cla…
Midas Rex Pneumatic Tools, Inc.1996—
*K952300Midas Rex Motors (Midas I, II & Convertible Models)
Summary page 1
…Affairs Midas Rex Motor (Midas IIT) Pneumatic Cranial Drill Motor Class I Midas Rex Motors, Midas (I, I, & Convertible) K953434 Class I Midas (1, IT, & Convertible) K952300 Class I Whirl Wind ™ ( Pre-1976) Midas GS and GS20 Surgical Tool System K952463 Class I Midas Drill Guide Attachment K954076 C…
Midas Rex Pneumatic Tools, Inc.1995—
*K952463GS & GS20 Surgical Tool System
Summary page 1
…as Rex Motors, Midas (I, I, & Convertible) K953434 Class I Midas (1, IT, & Convertible) K952300 Class I Whirl Wind ™ ( Pre-1976) Midas GS and GS20 Surgical Tool System K952463 Class I Midas Drill Guide Attachment K954076 Class I Midas Telescoping System K953433 Class I Btilmansafety D…
Midas Rex Pneumatic Tools, Inc.19951
*K954076Midas Rex Drill Attachments & Twist Drills
Summary page 1
…3434 Class I Midas (1, IT, & Convertible) K952300 Class I Whirl Wind ™ ( Pre-1976) Midas GS and GS20 Surgical Tool System K952463 Class I Midas Drill Guide Attachment K954076 Class I Midas Telescoping System K953433 Class I Btilmansafety Description Of the Device: Statement of Intende…
Midas Rex Pneumatic Tools, Inc.1995—
*K953433Midas Rex Telescoping System
Summary page 1
…K952300 Class I Whirl Wind ™ ( Pre-1976) Midas GS and GS20 Surgical Tool System K952463 Class I Midas Drill Guide Attachment K954076 Class I Midas Telescoping System K953433 Class I Btilmansafety Description Of the Device: Statement of Intended Use: Technological Characteristics: Er…
Midas Rex Pneumatic Tools, Inc.19952
*—Whirl Wind (Pre-1976)
Named without a submission number
—

Also cleared against K953434: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970965Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc.19970

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K970965 (Midas Rex Pneumatic Tools, Inc., 1997) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K953434.

How does its category compare?

All HBB devices

HBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBB

1in 2018

2007: 12009: 12010: 22015: 12017: 12018: 12026 (partial year): 1
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBB

Too few HBB 510(k)s in any year since 2007 to give a median.

Recalls per year · HBB

2in 2025

2007: 12008: 12009: 12013: 12015: 12017: 12025: 2
2007high 2 (2025) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBB

1,016in 2025

2007: 822008: 1762009: 1962010: 1832011: 3992012: 3792013: 6852014: 5622015: 4402016: 2732017: 2032018: 2952019: 2842020: 2632021: 2602022: 1722023: 1802024: 7592025: 1,016
2007high 1,016 (2025) · low 82 (2007)2025

MAUDE reports naming product code HBB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—182
20080—1176
20091—1196
20102—0183
20110—0399
20120—0379
20130—1685
20140—0562
20151—1440
20160—0273
20171—1203
20181—0295
20190—0284
20200—0263
20210—0260
20220—0172
20230—0180
20240—0759
20250—21,016
20261—0—

What is it indicated for?

The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K953434

1 other device cites the same predicate.

  • K972289Midas Rex MotorMidas Rex Pneumatic Tools, Inc. · 1997

More from Midas Rex Pneumatic Tools, Inc.

12 FDA decisions under this applicant name. See the company

  • K972289Midas Rex MotorMidas Rex Pneumatic Tools, Inc. · 1997
  • K970965Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc. · 1997
  • K953434Midas Rex Motors, (Midas I, Midas II & Convertible Models)Midas Rex Pneumatic Tools, Inc. · 1996
  • K954076Midas Rex Drill Attachments & Twist DrillsMidas Rex Pneumatic Tools, Inc. · 1995
  • K953433Midas Rex Telescoping SystemMidas Rex Pneumatic Tools, Inc. · 19952 recalls

Recent decisions in HBB

The HBB category page

  • K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AG · 2026
  • K172907ELAN 4 Air Motor SystemAesculap, Inc. · 20182 recalls
  • K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic…Medtronic Powered Surgical Solutions · 2017
  • K150801Stryker Maestro Air MotorsStryker Corporation · 20151 recall
  • K101168Legend Power Adapter Model: 6475000Medtronic Sofamor Danek · 2010

https://510kreport.com/device/K962483 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962483: Midas Rex Iii Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962483

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026