510(k) Report

FDA applicant

Qompium NV

Hasselt, BE2 decisions2018–20240 recalls

FDA records 2 decisions for Qompium NV (Hasselt, BE) from 2018 to 2024: 2 510(k) clearances. Most are in product codes QME (Software For Optical Camera-Based Measurement…) and DXH (Transmitters And Receivers…). Its devices cite 2 predicates, 1 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 Qompium NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Qompium NV by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate…1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K173872FibriCheckQompium NV · 20183cite it
  • K232804FibriCheckQompium NV · 20241cites it

What has FDA decided for it lately?

  • K232804FibriCheckQompium NV · 2024
  • K173872FibriCheckQompium NV · 2018

All 2 as Qompium NV →