FDA applicant

Tokyo Boeki Medisys, Inc.

Durham, NC2 decisions2011–20120 recalls

FDA records 2 decisions for Tokyo Boeki Medisys, Inc. (Durham, NC) from 2011 to 2012: 2 510(k) clearances. Most are in product codes CEM (Electrode, Ion Specific, Potassium) and CFR (Hexokinase, Glucose). Its devices cite 4 predicates, 0 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, clinical chemistry panel, where it files most

How often FDA has decided Tokyo Boeki Medisys, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Tokyo Boeki Medisys, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Tokyo Boeki Medisys, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?