510(k) Report

FDA applicant

Somas Medical Industries, Inc.

Mchenry, IL6 decisions1984–19860 recalls

FDA records 6 decisions for Somas Medical Industries, Inc. (Mchenry, IL) from 1984 to 1986: 6 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and CFM (Bathophenanthroline, Colorimetry, Iron…). 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 Somas Medical Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Somas Medical Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Somas Medical Industries, 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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