510(k) Report

FDA applicant

Eikon Healthcare Device Corp.

Hsin-Chu City,, TW2 decisions2002–20020 recalls

FDA records 2 decisions for Eikon Healthcare Device Corp. (Hsin-Chu City,, TW) in 2002: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). 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 Eikon Healthcare Device Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eikon Healthcare Device Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eikon Healthcare Device Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eikon Healthcare Device Corp.’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

Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

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.

  • K021239Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 20022cite it

What has FDA decided for it lately?

  • K021240Eikon Automatic Digital Blood Pressure Monitor, Model HD-200M/HD-200Eikon Healthcare Device Corp. · 2002
  • K021239Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002

All 2 as Eikon Healthcare Device Corp. →