510(k) · Cleared
ClearedOtoplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cascination AG · QQE Image Management Software For Planning Of Otologic And Neurotologic Procedures
Cleared on Aug 20, 2021 as substantially equivalent to K201465 (Surgical Theater, Inc., 2020) after a 266-day review. Its family tree reaches back 9 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 20, 2021
- Review
- 266 days
- Class
- Class II
- Product code
- QQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations between
- 3 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 2 generations backK170793 SuRgical Planner (SRP)Surgical Theater, LLC · 2018 · Recalled
- 1 generation backK201465 SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020 · Recalled
- This deviceK203486 OtoplanCascination AG · 2021
- Descendant · cites it directly · 0 of its ownK242120 OtoplanCascination AG · 2025
- Descendant · cites it directly · 0 of its ownK220300 OtoplanCascination AG · 2022
Show all 9 generations
- Root · 9 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 8 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 7 generations backK033849 Simplant SystemMaterialise NV · 2004
- 6 generations backK073468 MimicsMaterialise NV · 2008
- 5 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 4 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 3 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 2 generations backK170793 SuRgical Planner (SRP)Surgical Theater, LLC · 2018 · Recalled
- 1 generation backK201465 SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020 · Recalled
- This deviceK203486 OtoplanCascination AG · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −8 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −7 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −6 | K073468 | Mimics | Materialise NV | 2008 | — |
| −5 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −4 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −3 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −2 | K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | 2018 | 1 |
| −1 | K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | 2020 | 1 |
| 0 (this device) | K203486 | Otoplan | Cascination AG | 2021 | — |
| +1 | K242120 | Otoplan | Cascination AG | 2025 | — |
| +1 | K220300 | Otoplan | Cascination AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 QQE? 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 QQE device
- #1 K242120 Otoplanscore 11.9 · 10 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K201465 | SuRgical Planner (SRP) BrainStormSummary page 4…lass 1T Product Code: QQE Ill. PREDICATE DEVICE Primary Predicate Device Company: Surgical Theater, Inc. Device name: SuRgical Planner (SRP) BrainStorm 510(k) number: K201465 OTOPLAN Traditional 510(k) Premarket Notification Section: 5 - Page: 1… | 2020 |
| † | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine) | 2012 |
What descends from it? (2)
2 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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K242120 (Cascination AG, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201465.
How does its category compare?
All QQE devicesQQE Image Management Software For Planning Of Otologic And Neurotologic Procedures: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QQE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQE
Too few QQE 510(k)s in any year since 2007 to give a median.
Recalls per year · QQE
No recall names QQE since 2007.
Adverse event reports per year · QQE
No MAUDE report names QQE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).
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/K203486 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203486: Otoplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203486
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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