FDA applicant

Amicon, Inc.

Danvers, MA20 decisions1976–19930 recalls

FDA records 20 decisions for Amicon, Inc. (Danvers, MA) from 1976 to 1993: 20 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and JJH (Clinical Sample Concentrator). 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 Amicon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amicon, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Amicon, 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?