510(k) Report

FDA applicant

Metasystems GmbH

Germany, DE1 decision1995–19950 recalls

FDA records 1 decision for Metasystems GmbH (Germany, DE) in 1995: 1 510(k) clearance. All are in product code LNJ (Analyzer, Chromosome, Automated). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Metasystems GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Metasystems GmbH’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?

  • LNJAnalyzer, Chromosome, Automated1decision

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.

  • K940240IkarosMetasystems GmbH · 19951cites it

What has FDA decided for it lately?

  • K940240IkarosMetasystems GmbH · 1995

The one decision as Metasystems GmbH →