FDA applicant

Omron Tateisi Electronics Co.

Tokyo, 105 Japan, JP7 decisions1985–19880 recalls

FDA records 7 decisions for Omron Tateisi Electronics Co. (Tokyo, 105 Japan, JP) from 1985 to 1988: 7 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DRS (Transducer, Blood-Pressure, Extravascular). 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 Tateisi Electronics Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omron Tateisi Electronics Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Omron Tateisi Electronics Co.’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 “Omron”

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

Omron Healthcare, Inc. 69 Omron Electronics, Inc. 10 Omron Marshall Products, Inc. 3

Omron Tateisi Electronics Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Omron”