510(k) · Cleared
ClearedPrecisionTAVI (v1.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dasi Simulations · QQI Interventional Cardiovascular Implant Simulation Software Device
Cleared on May 30, 2023 as substantially equivalent to K214066 (Feops NV, 2022) after a 161-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- May 30, 2023
- Review
- 161 days
- Class
- Class II
- Product code
- QQI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200030 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QQI? 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 QQI device
- #1 K250635 FEops HEARTguide Simulation Applicationscore 10.7 · 2 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 |
|---|---|---|---|
| * | K214066 | FEops HEARTguideSummary page 4…ntional Cardiovascular Implant Simulation Software Device Regulation Number: 870.1405 Product Code: QQI PREDICATE DEVICE Predicate # K214066 Device Name: FEops HEARTguide Product Code: QQI… | 2022 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K214066.
How does its category compare?
All QQI devicesQQI Interventional Cardiovascular Implant Simulation Software Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QQI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQI
Too few QQI 510(k)s in any year since 2007 to give a median.
Recalls per year · QQI
No recall names QQI since 2007.
Adverse event reports per year · QQI
No MAUDE report names QQI 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 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning. The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes. The information provided by PrecisionTAVI is intended for use by cardiologists…
Read the full statement (131 words)
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning.
The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes.
The information provided by PrecisionTAVI is intended for use by cardiologists, radiologists, and clinical specialists, and 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. The clinician receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions.
PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223809: PrecisionTAVI (v1.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223809
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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