FDA applicant

Nihon Kohden Digital Health Solutions, LLC

Irvine, CA2 decisions2022–20250 recalls

FDA records 2 decisions for Nihon Kohden Digital Health Solutions, LLC (Irvine, CA) from 2022 to 2025: 2 510(k) clearances. Most are in product codes MSX (System, Network And Communication…) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nihon Kohden Digital Health Solutions, Inc.”.

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 Kohden Digital Health Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Nihon Kohden Digital Health Solutions, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nihon Kohden Digital Health Solutions…’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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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 Seimitsu Sokki Co., Ltd. 21 Nihon Kohden Orangemed, Inc. 5 Nihon Medix Co., Ltd. 1

Nihon Kohden Digital Health Solutions, LLC

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”