510(k) Report

FDA applicant

Preanalytix GmbH

Hombrechtikon, CH4 decisions2005–20230 recalls

FDA records 4 decisions for Preanalytix GmbH (Hombrechtikon, CH) from 2005 to 2023: 3 510(k) clearances and 1 De Novo grant. Most are in product codes PJE (Blood/Plasma Collection Device For Dna Testing) and NTW (System, Blood Collection, Rna Stabilization…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2023

2009: 12015: 12023: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Preanalytix GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PJEBlood/Plasma Collection Device For Dna Testing2decisions
  • NTWSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular…2decisions

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 4 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.

  • DEN050003Paxgene Blood Rna SystemPreanalytix GmbH · 20052cite it
  • K142821PAXgene Blood DNA TubePreanalytix GmbH · 20151cites it
  • K082150Modification to Paxgene Blood Rna SystemPreanalytix GmbH · 20091cites it

What has FDA decided for it lately?

  • K231469PAXgene® Blood DNA TubePreanalytix GmbH · 2023
  • K142821PAXgene Blood DNA TubePreanalytix GmbH · 2015
  • K082150Modification to Paxgene Blood Rna SystemPreanalytix GmbH · 2009
  • DEN050003Paxgene Blood Rna SystemPreanalytix GmbH · 2005

All 4 as Preanalytix GmbH →