FDA applicant

Kells Medical, Inc.

Mchenry, IL12 decisions1982–19930 recalls

FDA records 12 decisions for Kells Medical, Inc. (Mchenry, IL) from 1982 to 1993: 12 510(k) clearances. Most are in product codes KPE (Container, I.V.) and LIX (Aid, Cardiopulmonary Resuscitation). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Kells Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Kells Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?