510(k) · Cleared
ClearedELAN 4 Tools
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Aug 9, 2019 as substantially equivalent to K172709 (Aesculap, Inc., 2018) and 1 other predicate after a 263-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 9, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011444 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001 · Recalled
- 3 generations backK080802 Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware…The Anspach Effort, Inc. · 2008 · Recalled
- 2 generations backK113476 Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · Recalled
- 1 generation backK172709 ELAN 4 Electro Motor System ToolsAesculap, Inc. · 2018
- This deviceK183203 ELAN 4 ToolsAesculap, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | 2001 | 70 |
| −3 | K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade… | The Anspach Effort, Inc. | 2008 | 35 |
| −2 | K113476 | Anspach Dissection Tools | The Anspach Effort, Inc. | 2011 | 39 |
| −1 | K172709 | ELAN 4 Electro Motor System Tools | Aesculap, Inc. | 2018 | — |
| 0 (this device) | K183203 | ELAN 4 Tools | Aesculap, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 13.1 · 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? (2)
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 |
|---|---|---|---|
| * | K172709 | ELAN 4 Electro Motor System ToolsSummary page 4…ATION NUMBER: 882.4310 PRODUCT CODE: HBE SUBSTANTIAL EQUIVALENCE The ELAN 4 Tools are substantially equivalent to the primary predicate, ELAN 4 Tools (K172709) and predicate Anspach Dissection Tools (K113476). DEVICE DESCRIPTION The ELAN 4 Tools are cutting devices designed for use with… | 2018 |
| * | K113476 | Anspach Dissection ToolsSummary page 4…HBE SUBSTANTIAL EQUIVALENCE The ELAN 4 Tools are substantially equivalent to the primary predicate, ELAN 4 Tools (K172709) and predicate Anspach Dissection Tools (K113476). DEVICE DESCRIPTION The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tool… | 2011 |
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 18 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 4 of the 5 ancestors have a recall of any class.
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. 2019, 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?
Aesculap ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183203: ELAN 4 Tools.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183203
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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