510(k) Report

FDA applicant

Sim&Cure

Montpellier, FR6 decisions2019–20250 recalls

FDA records 6 decisions for Sim&Cure (Montpellier, FR) from 2019 to 2025: 6 510(k) clearances. All are in product code PZO (Software For Visualization Of Vascular Anatomy…). Its devices cite 6 predicates, 5 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, radiology panel, where it files most

How often FDA has decided Sim&Cure’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12020: 12022: 12023: 12024: 12025: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Sim&Cure by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sim&Cure’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PZOSoftware For Visualization Of Vascular Anatomy And Intravascular Devices6decisions

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K202322Sim&SizeSim&Cure · 20202cite it
  • K190049Sim&SizeSim&Cure · 20192cite it
  • K222664Sim&SizeSim&Cure · 20231cites it
  • K242124Sim&SizeSim&Cure · 20241cites it
  • K212373Sim&SizeSim&Cure · 20221cites it

What has FDA decided for it lately?

All 6 as Sim&Cure →