De Novo · Granted
GrantedFEops HEARTguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Feops NV · QQI Interventional Cardiovascular Implant Simulation Software Device
Granted on Sep 8, 2021 as a new device type through De Novo after a 489-day review. 3 later devices descend from it.
- Decided
- Sep 8, 2021
- Review
- 489 days
- Class
- Class II
- Product code
- QQI
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN200030 FEops HEARTguideFeops NV · 2021
- Descendant · cites it directly · 2 of its ownK214066 FEops HEARTguideFeops NV · 2022
- Descendant · 2 generations on · 0 of its ownK250635 FEops HEARTguide Simulation ApplicationFeops NV · 2025
- Descendant · 2 generations on · 0 of its ownK223809 PrecisionTAVI (v1.1)Dasi Simulations · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200030 | FEops HEARTguide | Feops NV | 2021 | — |
| +1 | K214066 | FEops HEARTguide | Feops NV | 2022 | — |
| +2 | K250635 | FEops HEARTguide Simulation Application | Feops NV | 2025 | — |
| +2 | K223809 | PrecisionTAVI (v1.1) | Dasi Simulations | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214066 | FEops HEARTguide | 2022 | 2 |
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?
- Of its descendants, K214066 (Feops NV, 2022) has gone furthest, with 2 descendants of its own.
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. 2021, 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?
FEops HEARTguide is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. FEops HEARTguide is intended to be used by qualified clinicians in conjunction with the simulated device instructions-for-use, the patient’s clinical…
Read the full statement (98 words)
FEops HEARTguide is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide is intended to be used by qualified clinicians in conjunction with the simulated device instructions-for-use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide is not intended to replace the simulated device’s instructions for use for final LAAO device selection and placement.
FEops HEARTguide is prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200030 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200030: FEops HEARTguide.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200030
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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