510(k) · Cleared
ClearedZeppelin Motor Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Von Zeppelin Chirurgische Instrumente GmbH · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Oct 13, 1992 after a 151-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 13, 1992
- Review
- 151 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK922299 Zeppelin Motor Drill SystemVon Zeppelin Chirurgische Instrumente GmbH · 1992
- Descendant · cites it directly · 6 of its ownK013091 ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002
- Descendant · cites it directly · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
- Descendant · 2 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
- Descendant · 3 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 · 4 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 · cites it directly4descendants
- K232684Surgify HaloSurgify Medical OY · 2023 · 2 generations on3descendants
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 3 generations on2descendants
- K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922299 | Zeppelin Motor Drill System | Von Zeppelin Chirurgische Instrumente GmbH | 1992 | — |
| +1 | K013091 | ZMM 2000 Zeppelin Millennium Motordrill System | Von Zeppelin GmbH | 2002 | — |
| +1 | K130755 | Hicut Highspeed Instrument | Adeor Medical AG | 2014 | — |
| +2 | K232684 | Surgify Halo | Surgify Medical OY | 2023 | — |
| +3 | K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo… | Surgify Medical OY | 2025 | 5 |
| +4 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
3 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, K013091 (Von Zeppelin GmbH, 2002) has gone furthest, with 6 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K922299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922299: Zeppelin Motor Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922299
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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