FDA applicant

Aesku Diagnostics

Wendelsheim, Rheinland, DE11 decisions2004–20180 recalls

FDA records 11 decisions for Aesku Diagnostics (Wendelsheim, Rheinland, DE) from 2004 to 2018: 11 510(k) clearances. Most are in product codes LSW (Anti-Dna Antibody, Antigen And Control) and MOB (Test System, Antineutrophil Cytoplasmic…). No recall is linked to its devices.

FDA’s records also spell it “Aesku.Diagnostics GmbH & Co. KG”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

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

FDA decisions per year

2in 2018

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Aesku”

FDA records each applicant name separately; these may or may not be the same firm.

Aesku, Inc. 6 Aesku Systems GmbH&Co.Kg 1

Aesku Diagnostics

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Aesku”