510(k) Report

FDA applicant

Actus, Inc.

Mchenry, IL4 decisions1977–19780 recalls

FDA records 4 decisions for Actus, Inc. (Mchenry, IL) from 1977 to 1978: 4 510(k) clearances. Most are in product codes JJJ (Counter (Beta, Gamma) For Clinical Use) and IZD (Probe, Uptake, Nuclear). 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 Actus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Actus, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Actus, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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