510(k) · Cleared
ClearedFEops HEARTguide Simulation Application
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
Cleared on Nov 25, 2025 as substantially equivalent to K214066 (Feops NV, 2022) after a 267-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Nov 25, 2025
- Review
- 267 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 K214066 FEops HEARTguidescore 8.9 · 1 generation · 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 5…ification Name Interventional Cardiovascular Implant Simulation Software Device Premarket notification number K214066 Trade or proprietary or model name FEops HEARTguide Original Applicant FEops nv Regulation Number… | 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 4 years and passes through 1 company; a new generation was cleared every 3.7 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. 2025, 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™ Simulation Application 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™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated…
Read the full statement (100 words)
FEops HEARTguide™ Simulation Application 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™ Simulation Application 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™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250635: FEops HEARTguide Simulation Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250635
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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