510(k) Report

FDA applicant

Tokyo Boeki Medical System, Ltd.

Raleigh, NC1 decision2005–20050 recalls

FDA records 1 decision for Tokyo Boeki Medical System, Ltd. (Raleigh, NC) in 2005: 1 510(k) clearance. All are in product code JJE (Analyzer, Chemistry (Photometric, Discrete)…). Its devices cite 1 predicate, 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 Medical System, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tokyo Boeki Medical System, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tokyo Boeki Medical System, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tokyo Boeki Medical System, 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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Which product codes does it file in?

  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040958Prestige Models 24I and 400 and MGC Model 240Tokyo Boeki Medical System, Ltd. · 20052cite it

What has FDA decided for it lately?

  • K040958Prestige Models 24I and 400 and MGC Model 240Tokyo Boeki Medical System, Ltd. · 2005

The one decision as Tokyo Boeki Medical System, Ltd. →