FDA applicant

Abtox, Inc.

Mundelein, IL3 decisions1994–19940 recalls

FDA records 3 decisions for Abtox, Inc. (Mundelein, IL) in 1994: 3 510(k) clearances. Most are in product codes FLF (Sterilizer, Ethylene-Oxide Gas) and FRC (Indicator, Biological Sterilization Process). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Abtox, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Abtox, Inc.

Which product codes does it file in?

What has FDA decided for it lately?