FDA applicant

Omron Electronics, Inc.

Schaumburg, IL10 decisions1987–19900 recalls

FDA records 10 decisions for Omron Electronics, Inc. (Schaumburg, IL) from 1987 to 1990: 10 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Omron Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Omron”

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

Omron Healthcare, Inc. 69 Omron Tateisi Electronics Co. 7 Omron Marshall Products, Inc. 3

Omron Electronics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Omron”