FDA applicant

Erika, Inc.

Mchenry, IL43 decisions1976–19850 recalls

FDA records 43 decisions for Erika, Inc. (Mchenry, IL) from 1976 to 1985: 43 510(k) clearances. Most are in product codes KOC (Accessories, Blood Circuit, Hemodialysis) and FJI (Dialyzer, Capillary, Hollow Fiber). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Erika, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Erika, 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?