510(k) · Cleared
ClearedMidas Rex Motors, (Midas I, Midas II & Convertible Models)
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 May 16, 1996 after a 300-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- May 16, 1996
- Review
- 300 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK953434 Midas Rex Motors, (Midas I, Midas II & Convertible Models)Midas Rex Pneumatic Tools, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK962483 Midas Rex Iii MotorMidas Rex Pneumatic Tools, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK972289 Midas Rex MotorMidas Rex Pneumatic Tools, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK970965 Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K962483Midas Rex Iii MotorMidas Rex Pneumatic Tools, Inc. · 1996 · cites it directly1descendant
- K972289Midas Rex MotorMidas Rex Pneumatic Tools, Inc. · 1997 · cites it directly0descendants
- K970965Midas Rex Iii Motor and Attachments (Midas Iii)Midas Rex Pneumatic Tools, Inc. · 1997 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953434 | Midas Rex Motors, (Midas I, Midas II & Convertible Models) | Midas Rex Pneumatic Tools, Inc. | 1996 | — |
| +1 | K962483 | Midas Rex Iii Motor | Midas Rex Pneumatic Tools, Inc. | 1996 | — |
| +1 | K972289 | Midas Rex Motor | Midas Rex Pneumatic Tools, Inc. | 1997 | — |
| +2 | K970965 | Midas Rex Iii Motor and Attachments (Midas Iii) | Midas Rex Pneumatic Tools, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
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 |
|---|---|---|---|
| * | — | Midas Rex Whirlwind™ Motor Named without a submission number | |
| † | K952300 | Midas Rex Motors (Midas I, II & Convertible Models) | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K962483 (Midas Rex Pneumatic Tools, Inc., 1996) has gone furthest, with 1 descendant of its own.
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?
To provide power to operate removable rotating surgical cutting tools or drill bits on a patient’s skull.
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/K953434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953434: Midas Rex Motors, (Midas I, Midas II & Convertible Models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953434
Report an extraction error
Are you the manufacturer?
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