FDA applicant

Sein Electronics Co., Ltd.

Mahwah, NJ12 decisions1991–20050 recalls

FDA records 12 decisions for Sein Electronics Co., Ltd. (Mahwah, NJ) from 1991 to 2005: 12 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 6 predicates, 4 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 Sein Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sein Electronics Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sein Electronics Co., Ltd.’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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Sein Electronics 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?