510(k) · Cleared
ClearedMidas Rex Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midas Rex Pneumatic Tools, Inc. · HBB Motor, Drill, Pneumatic
Cleared on Sep 12, 1997 as substantially equivalent to K953434 (Midas Rex Pneumatic Tools, Inc., 1996) after an 85-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 12, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953434 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK953434 Midas Rex Motors, (Midas I, Midas II & Convertible Models)Midas Rex Pneumatic Tools, Inc. · 1996
- This deviceK972289 Midas Rex MotorMidas Rex Pneumatic Tools, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953434 | Midas Rex Motors, (Midas I, Midas II & Convertible Models) | Midas Rex Pneumatic Tools, Inc. | 1996 | — |
| 0 (this device) | K972289 | Midas Rex Motor | Midas Rex Pneumatic Tools, Inc. | 1997 | — |
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 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953434 | Midas Rex Motors, (Midas I, Midas II & Convertible Models)Summary page 1…el Fowler Director Regulatory Affairs Midas Rex Motor (MRIV) Pneumatic Cranial Drill Motor 882.4370 84 HBB Class I Midas Rex Motors, Midas I, Midas II & Convertible K 953434 The Midas Rex MRIV motor is an Ergonomically, designed lightweight variable speed motor, with a small overall diameter. The mot… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K953434.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBB
1in 2018
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBB
1,016in 2025
MAUDE reports naming product code HBB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 82 |
| 2008 | 0 | — | 1 | 176 |
| 2009 | 1 | — | 1 | 196 |
| 2010 | 2 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 399 |
| 2012 | 0 | — | 0 | 379 |
| 2013 | 0 | — | 1 | 685 |
| 2014 | 0 | — | 0 | 562 |
| 2015 | 1 | — | 1 | 440 |
| 2016 | 0 | — | 0 | 273 |
| 2017 | 1 | — | 1 | 203 |
| 2018 | 1 | — | 0 | 295 |
| 2019 | 0 | — | 0 | 284 |
| 2020 | 0 | — | 0 | 263 |
| 2021 | 0 | — | 0 | 260 |
| 2022 | 0 | — | 0 | 172 |
| 2023 | 0 | — | 0 | 180 |
| 2024 | 0 | — | 0 | 759 |
| 2025 | 0 | — | 2 | 1,016 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Midas Rex MRIV pneumatic motor provides power to operate an assortment of
rotating surgical cutting tools. The motor is intended for skull based bone dissection
and other microsurgical applications, including specialties in which a lightweight,
high-speed bone dissecting system can be used in or near a magnetic field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972289: Midas Rex Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972289
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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