510(k) · Cleared
ClearedVelocity Alpha Highspeed Surgical Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adeor Medical AG · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Apr 11, 2021 as substantially equivalent to K152960 (Aesculap, Inc., 2016) after a 677-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 11, 2021
- Review
- 677 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943589 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK943589 Stryker Total Performance SystemStryker Corp. · 1994
- 2 generations backK053526 Microspeed Uni Motor SystemAesculap, Inc. · 2006 · Recalled
- 1 generation backK152960 ELAN 4 Motor SystemAesculap, Inc. · 2016
- This deviceK191479 Velocity Alpha Highspeed Surgical Drill SystemAdeor Medical AG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943589 | Stryker Total Performance System | Stryker Corp. | 1994 | — |
| −2 | K053526 | Microspeed Uni Motor System | Aesculap, Inc. | 2006 | 1 |
| −1 | K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016 | — |
| 0 (this device) | K191479 | Velocity Alpha Highspeed Surgical Drill System | Adeor Medical AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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 HBE? 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 HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K152960 | ELAN 4 Motor SystemSummary page 4…Market device claiming equivalence to: The electric drill system is substantially equivalent to the Aesculap ELAN 4 Electro Motor System cleared via K152960. X. Device Description: The Velocity AlphaT m Highspeed Surgical Drill System is an electric AC powered surgical… | 2016 |
| † | K130755 | Hicut Highspeed Instrument | 2014 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K152960.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, 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 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191479: Velocity Alpha Highspeed Surgical Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191479
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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