FDA applicant

Aesku, Inc.

Miami, FL6 decisions2003–20061 recall

FDA records 6 decisions for Aesku, Inc. (Miami, FL) from 2003 to 2006: 6 510(k) clearances. Most are in product codes MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2…) and MVM (Autoantibodies, Endomysial (Tissue…). 1 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Aesku, Inc. since 2007.

Recalls per year

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Aesku, Inc.’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

Other applicant names beginning “Aesku”

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

Aesku Diagnostics 11 Aesku Systems GmbH&Co.Kg 1

Aesku, Inc.

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?

What has been recalled?

Other applicant names beginning “Aesku”