510(k) Report

FDA applicant

Digibio Technology Corp.

Plano, TX1 decision2002–20020 recalls

FDA records 1 decision for Digibio Technology Corp. (Plano, TX) in 2002: 1 510(k) clearance. 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 Digibio Technology Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digibio Technology Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

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.

  • K014141Digibio Digtial Blood Pressure Monitor Model D11Digibio Technology Corp. · 20022cite it

What has FDA decided for it lately?

  • K014141Digibio Digtial Blood Pressure Monitor Model D11Digibio Technology Corp. · 2002

The one decision as Digibio Technology Corp. →