510(k) · Cleared
ClearedVelocity Alpha MR High Speed Surgical Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adeor Medical AG · HBB Motor, Drill, Pneumatic
Cleared on Mar 6, 2026 as substantially equivalent to K061725 (Stryker Instruments, 2006) after a 100-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Mar 6, 2026
- Review
- 100 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061725 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK061725 Stryker Aria Pneumatic SystemStryker Instruments · 2006
- This deviceK253772 Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061725 | Stryker Aria Pneumatic System | Stryker Instruments | 2006 | — |
| 0 (this device) | K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | 2026 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K061725 | Stryker Aria Pneumatic SystemSummary page 5…Class II VIII. Product Code: HBB, HBE IX. Primary Predicate Device: Stryker Aria Pneumatic System (K061725) X. Device Description: The Velocity Alpha MR High Speed Surgical Drill System is a pneumatic powered surgical moto… | 2006 |
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.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 Velocity Alpha MR High Speed Surgical Drill System is indicated for trephination, incision, cutting, removal,
shaping, sawing of soft and hard tissue, bone and biomaterials in or near a magnetic field of 3.0 Tesla or less for use in
Neurosurgery
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/K253772 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253772: Velocity Alpha MR High Speed Surgical Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253772
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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