510(k) · Cleared
ClearedMicrospeed EC Motorsystem GD650/GD653
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HBC Motor, Drill, Electric
Cleared on Feb 20, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Feb 20, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK003612 Microspeed EC Motorsystem GD650/GD653Aesculap, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK053526 Microspeed Uni Motor SystemAesculap, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK152960 ELAN 4 Motor SystemAesculap, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK213221 AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K053526Microspeed Uni Motor SystemAesculap, Inc. · 2006 · cites it directly12descendants
- K132264PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013 · 2 generations on6descendants
- K152960ELAN 4 Motor SystemAesculap, Inc. · 2016 · 2 generations on3descendants
- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 3 generations on1descendant
- K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003612 | Microspeed EC Motorsystem GD650/GD653 | Aesculap, Inc. | 2001 | — |
| +1 | K053526 | Microspeed Uni Motor System | Aesculap, Inc. | 2006 | 1 |
| +2 | K132264 | PRIMADO2 Total Surgical System | Nakanishi, Inc. | 2013 | — |
| +2 | K152960 | ELAN 4 Motor System | Aesculap, Inc. | 2016 | — |
| +3 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
| +3 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 153 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, K053526 (Aesculap, Inc., 2006) has gone furthest, with 12 descendants of its own.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, 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 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K003612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003612: Microspeed EC Motorsystem GD650/GD653.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003612
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026