510(k) · Cleared
ClearedFEops 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
Cleared on Feb 25, 2022 as substantially equivalent to DEN200030 (Feops NV, 2021) after a 60-day review. Its family tree reaches back 1 generation to 2021. 2 later devices descend from it.
- Decided
- Feb 25, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- QQI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200030 (2021). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN200030 FEops HEARTguideFeops NV · 2021
- This deviceK214066 FEops HEARTguideFeops NV · 2022
- Descendant · cites it directly · 0 of its ownK250635 FEops HEARTguide Simulation ApplicationFeops NV · 2025
- Descendant · cites it directly · 0 of its ownK223809 PrecisionTAVI (v1.1)Dasi Simulations · 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 |
|---|---|---|---|---|---|
| −1 | DEN200030 | FEops HEARTguide | Feops NV | 2021 | — |
| 0 (this device) | K214066 | FEops HEARTguide | Feops NV | 2022 | — |
| +1 | K250635 | FEops HEARTguide Simulation Application | Feops NV | 2025 | — |
| +1 | K223809 | PrecisionTAVI (v1.1) | Dasi Simulations | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | DEN200030 | FEops HEARTguideSummary page 4…to which substantial equivalence is claimed: Trade or proprietary or model name FEops HEARTguide™ De Novo class II petition: DEN200030 Decision date 08 SEP 2021 Classification product code QQI Regula… | 2021 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K250635 (Feops NV, 2025) has gone furthest, with 0 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. 2022, 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 history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ 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/K214066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214066: FEops HEARTguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214066
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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