510(k) Report

FDA applicant

Fortifier International Co., Ltd.

Hsin Chu City, TW1 decision2004–20040 recalls

FDA records 1 decision for Fortifier International Co., Ltd. (Hsin Chu City, TW) in 2004: 1 510(k) clearance. All are in product code DXN (System, Measurement, Blood-Pressure…). 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, cardiovascular panel, where it files most

How often FDA has decided Fortifier International Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fortifier International Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fortifier International Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fortifier International Co., Ltd.’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-Invasive1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K041400Fortifier Digital Wrist Blood Pressure Monitor, Model LF-01Fortifier International Co., Ltd. · 2004

The one decision as Fortifier International Co., Ltd. →