510(k) · Cleared
ClearedAnkyras
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentice Spain S.L. · PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Cleared on May 6, 2025 as substantially equivalent to K230006 (Mentice Spain S.L., 2023) after a 105-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- May 6, 2025
- Review
- 105 days
- Class
- Class II
- Product code
- PZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954678 (1996). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations between
- 3 generations backK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- 2 generations backK190049 Sim&SizeSim&Cure · 2019
- 1 generation backK230006 AnkyrasMentice Spain S.L. · 2023
- This deviceK250160 AnkyrasMentice Spain S.L. · 2025
Show all 11 generations
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 9 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 8 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 7 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 6 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 5 generations backK141475 EndosizeTherenva Sas · 2014
- 4 generations backK160376 EndoSizeTherenva Sas · 2016
- 3 generations backK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- 2 generations backK190049 Sim&SizeSim&Cure · 2019
- 1 generation backK230006 AnkyrasMentice Spain S.L. · 2023
- This deviceK250160 AnkyrasMentice Spain S.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −10 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −9 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −8 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −7 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −6 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −5 | K141475 | Endosize | Therenva Sas | 2014 | — |
| −4 | K160376 | EndoSize | Therenva Sas | 2016 | — |
| −3 | K171534 | SurgicalPreview | Endo Vantage, LLC | 2017 | — |
| −2 | K190049 | Sim&Size | Sim&Cure | 2019 | — |
| −1 | K230006 | Ankyras | Mentice Spain S.L. | 2023 | — |
| 0 (this device) | K250160 | Ankyras | Mentice Spain S.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 PZO? 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 PZO device
- #1 K242124 Sim&Sizescore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K230006 | AnkyrasSummary page 5…ULATION NAME: Medical Image Management and Processing system PRODUCT CODE: PZO PREDICATE DEVICE: ANKYRAS (Mentice Spain S.L.; K230006) K250160 - Page 2 of 6 Dev… | 2023 |
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 8 companies; a new generation was cleared every 2.3 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All PZO devicesPZO Software For Visualization Of Vascular Anatomy And Intravascular Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PZO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZO
Too few PZO 510(k)s in any year since 2007 to give a median.
Recalls per year · PZO
No recall names PZO since 2007.
Adverse event reports per year · PZO
No MAUDE report names PZO 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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: • Segmentation of neurovascular structures* • Semi-automatic centerline generation from segmented blood vessels* • Visualization of X-ray based…
Read the full statement (136 words)
ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.
ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices.
General functionalities are provided such as:
• Segmentation of neurovascular structures*
• Semi-automatic centerline generation from segmented blood vessels*
• Visualization of X-ray based images*
• Placing and sizing tools for braided endovascular devices
• Save user data
• Download** and share simulation***
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition.
ANKYRAS is available in different platforms: Standalone, WebGL and Mobile App.
*Available for Standalone and WebGL platforms
**Available for WebGL platform
***Available for WebGL and Mobile App platforms
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250160 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250160: Ankyras.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250160
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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