510(k) Report

FDA applicant

Germitec

Bordeaux, FR1 decision2024–20240 recalls

FDA records 1 decision for Germitec (Bordeaux, FR) in 2024: 1 De Novo grant. All are in product code SCS (Ultraviolet Radiation Disinfection Chamber…). 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Germitec by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SCSUltraviolet Radiation Disinfection Chamber Device1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

What has FDA decided for it lately?

The one decision as Germitec →