510(k) Report

FDA applicant

Curetis GmbH

Holzgerlingen, DE2 decisions2018–20190 recalls

FDA records 2 decisions for Curetis GmbH (Holzgerlingen, DE) from 2018 to 2019: 1 510(k) clearance and 1 De Novo grant. All are in product code QBH (Lower Respiratory Microbial Nucleic Acid…). Its devices cite 1 predicate, 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Curetis GmbH 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?

  • QBHLower Respiratory Microbial Nucleic Acid Detection System2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • DEN170047Curetis Unyvero LRT ApplicationCuretis GmbH · 20182cite it

What has FDA decided for it lately?

  • K191967Unyvero LRT BAL ApplicationCuretis GmbH · 2019
  • DEN170047Curetis Unyvero LRT ApplicationCuretis GmbH · 2018

All 2 as Curetis GmbH →