510(k) · Cleared
ClearedAesculap Hilan Motor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HBB Motor, Drill, Pneumatic
Cleared on Sep 2, 1998 as substantially equivalent to K973736 (Aesculap, Inc., 1997) after a 191-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- Sep 2, 1998
- Review
- 191 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973736 (1997). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK973736 Aesculap Hilan Motor SystemAesculap, Inc. · 1997
- This deviceK980686 Aesculap Hilan Motor SystemAesculap, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK013091 ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002
- Descendant · 2 generations on · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- Descendant · 3 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
- Descendant · 4 generations on · 2 of its ownK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
- Descendant · 5 generations on · 1 of its ownK251433 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K013091ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002 · cites it directly6descendants
- K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014 · 2 generations on4descendants
- K232684Surgify HaloSurgify Medical OY · 2023 · 3 generations on3descendants
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 4 generations on2descendants
- K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973736 | Aesculap Hilan Motor System | Aesculap, Inc. | 1997 | — |
| 0 (this device) | K980686 | Aesculap Hilan Motor System | Aesculap, Inc. | 1998 | — |
| +1 | K013091 | ZMM 2000 Zeppelin Millennium Motordrill System | Von Zeppelin GmbH | 2002 | — |
| +2 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| +3 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| +4 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 5 |
| +5 | K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | K973736 | Aesculap Hilan Motor SystemSummary page 1…gical Characteristics The HiLan Motor System for Neurosurgery is identical in all technological characteristics to the HiLan Pneumatic Motor System which was cleared in K973736. Performance Standards No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmet… | 1997 |
| * | — | corresponding devices distributed by Aesculap Named without a submission number | |
| * | — | corresponding devices distributed by Hall/Zimmer Named without a submission number | |
| * | — | corresponding devices distributed by Midas Rex Named without a submission number |
What descends from it? (9)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K013091 (Von Zeppelin GmbH, 2002) has gone furthest, with 6 descendants 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?
Aesculap’s HiLan Motor System for Neurosurgery is a pneumatic motor system intended for use in surgical procedures to provide power to operate removable cutting tools or drill bits on a patlents skull. It is indicated 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/K980686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980686: Aesculap Hilan Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980686
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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