FDA applicant

Nihon Seimitsu Sokki Co., Ltd.

Shibukawa-Shi, Gunma-Ken, JP21 decisions1985–20120 recalls

FDA records 21 decisions for Nihon Seimitsu Sokki Co., Ltd. (Shibukawa-Shi, Gunma-Ken, JP) from 1985 to 2012: 21 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and MNW (Analyzer, Body Composition). Its devices cite 24 predicates, 15 of them its own earlier devices. 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 Nihon Seimitsu Sokki Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2012

2007high 3 (2012) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nihon Seimitsu Sokki Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nihon Seimitsu Sokki Co., Ltd.’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 “Nihon”

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

Nihon Kohden America, Inc. 166 Nihon Kohden Corporation 31 Nihon Kohden Orangemed, Inc. 5 Nihon Kohden Digital Health Solutions, LLC 2 Nihon Medix Co., Ltd. 1

Nihon Seimitsu Sokki Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Nihon”