510(k) Report

FDA applicant

Feops NV

Gent-Zwijnaarde, BE4 decisions2021–20250 recalls

FDA records 4 decisions for Feops NV (Gent-Zwijnaarde, BE) from 2021 to 2025: 3 510(k) clearances and 1 De Novo grant. Most are in product codes QQI (Interventional Cardiovascular Implant…) and QIH (Automated Radiological Image Processing Software). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Feops NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 12023: 12025: 1
2021high 1 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Feops NV by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QQIInterventional Cardiovascular Implant Simulation Software Device3decisions
  • QIHAutomated Radiological Image Processing Software1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K214066FEops HEARTguideFeops NV · 20222cite it
  • DEN200030FEops HEARTguideFeops NV · 20211cites it

What has FDA decided for it lately?

  • K250635FEops HEARTguide Simulation ApplicationFeops NV · 2025
  • K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV · 2023
  • K214066FEops HEARTguideFeops NV · 2022
  • DEN200030FEops HEARTguideFeops NV · 2021

All 4 as Feops NV →