510(k) Report

FDA applicant

Omega Medical Electronics

Mchenry, IL21 decisions1982–19830 recalls

FDA records 21 decisions for Omega Medical Electronics (Mchenry, IL) from 1982 to 1983: 21 510(k) clearances. Most are in product codes CFJ (Nad Reduction/Nadh Oxidation, Lactate…) and CHD (Acid, Ferric Ion-Sulfuric, Cholesterol). 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 Omega Medical Electronics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Medical Electronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Omega”

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