510(k) · Cleared
ClearedSim&Size
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sim&Cure · PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Cleared on Jan 27, 2023 as substantially equivalent to K212373 (Sim&Cure, 2022) after a 147-day review. Its family tree reaches back 12 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 27, 2023
- Review
- 147 days
- Class
- Class II
- Product code
- PZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954678 (1996). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations between
- 3 generations backK190049 Sim&SizeSim&Cure · 2019
- 2 generations backK202322 Sim&SizeSim&Cure · 2020
- 1 generation backK212373 Sim&SizeSim&Cure · 2022
- This deviceK222664 Sim&SizeSim&Cure · 2023
- Descendant · cites it directly · 1 of its ownK242124 Sim&SizeSim&Cure · 2024
- Descendant · 2 generations on · 0 of its ownK253122 Sim&SizeSim&Cure · 2025
Show all 12 generations
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 11 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 10 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 9 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 8 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 7 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 6 generations backK141475 EndosizeTherenva Sas · 2014
- 5 generations backK160376 EndoSizeTherenva Sas · 2016
- 4 generations backK171534 SurgicalPreviewEndo Vantage, LLC · 2017
- 3 generations backK190049 Sim&SizeSim&Cure · 2019
- 2 generations backK202322 Sim&SizeSim&Cure · 2020
- 1 generation backK212373 Sim&SizeSim&Cure · 2022
- This deviceK222664 Sim&SizeSim&Cure · 2023
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 |
|---|---|---|---|---|---|
| −12 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −11 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −10 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −9 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −8 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −7 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −6 | K141475 | Endosize | Therenva Sas | 2014 | — |
| −5 | K160376 | EndoSize | Therenva Sas | 2016 | — |
| −4 | K171534 | SurgicalPreview | Endo Vantage, LLC | 2017 | — |
| −3 | K190049 | Sim&Size | Sim&Cure | 2019 | — |
| −2 | K202322 | Sim&Size | Sim&Cure | 2020 | — |
| −1 | K212373 | Sim&Size | Sim&Cure | 2022 | — |
| 0 (this device) | K222664 | Sim&Size | Sim&Cure | 2023 | — |
| +1 | K242124 | Sim&Size | Sim&Cure | 2024 | — |
| +2 | K253122 | Sim&Size | Sim&Cure | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K212373 | Sim&SizeSummary page 4…ular Devices Common Name: Medical image management and processing system Regulation Number: 892.2050 Class: II Product Code: PZO 3. Predicate Device K212373 - Sim&Size, Sim&Cure. 4. Device Description Sim&Size is a Software as a Medical Device (SaMD) for the simulation of neurova… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242124 | Sim&Size | 2024 | 1 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K242124 (Sim&Cure, 2024) has gone furthest, with 1 descendant of its own.
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. 2023, 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?
Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular
interventions and surgery.
Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices.
General functionalities are provided such as:
- Segmentation of neurovascular structures
- Automatic centerline detection
- Visualization of X-Ray based images for 2D review and 3D reconstruction
- Placing and sizing tools
- Reporting tools
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222664: Sim&Size.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222664
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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