FDA applicant

Axiom, Inc.

Mchenry, IL4 decisions1984–19890 recalls

FDA records 4 decisions for Axiom, Inc. (Mchenry, IL) from 1984 to 1989: 4 510(k) clearances. Most are in product codes CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…) and KNK (Acid, Uric, Uricase (Colorimetric)). 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 Axiom, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Axiom, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Axiom, 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 “Axiom”

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

Axiom Medical, Inc. 28 Axiom Worldwide, Inc. 4 Axiom Usa., Inc. 4 Axiom Manufacturing 2 Axiom Orthopaedics, Inc. 1 Axiom Ent. Co., Ltd. 1 Axiom Technology Partners, LLC 1

Axiom, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Axiom”