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 Jun 24, 2022 as substantially equivalent to K203486 (Cascination AG, 2021) after a 142-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Jun 24, 2022
- Review
- 142 days
- Class
- Class II
- Product code
- QQE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations between
- 3 generations backK170793 SuRgical Planner (SRP)Surgical Theater, LLC · 2018 · Recalled
- 2 generations backK201465 SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020 · Recalled
- 1 generation backK203486 OtoplanCascination AG · 2021
- This deviceK220300 OtoplanCascination AG · 2022
Show all 10 generations
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 9 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 8 generations backK033849 Simplant SystemMaterialise NV · 2004
- 7 generations backK073468 MimicsMaterialise NV · 2008
- 6 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 5 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 4 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 3 generations backK170793 SuRgical Planner (SRP)Surgical Theater, LLC · 2018 · Recalled
- 2 generations backK201465 SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020 · Recalled
- 1 generation backK203486 OtoplanCascination AG · 2021
- This deviceK220300 OtoplanCascination AG · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −9 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −8 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −7 | K073468 | Mimics | Materialise NV | 2008 | — |
| −6 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −5 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −4 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −3 | K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | 2018 | 1 |
| −2 | K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | 2020 | 1 |
| −1 | K203486 | Otoplan | Cascination AG | 2021 | — |
| 0 (this device) | K220300 | Otoplan | Cascination AG | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K203486 | OtoplanSummary page 5…CE Primary Predicate Device Company: CASCINATION AG, Steigerhubelstrasse 3, CH-3008 Bern, Switzerland Device name: OTOPLAN 510(k) number: K203486 IV. DEVICE DESCRIPTION OTOPLAN consolidates a DICOM viewer, ruler function, and calculator function into one software platform… | 2021 |
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 29 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K203486.
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. 2022, 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/K220300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220300: Otoplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220300
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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