510(k) Report

FDA applicant

Ostar Meditech Corp.

Taipei Hsien, TW2 decisions2005–20110 recalls

FDA records 2 decisions for Ostar Meditech Corp. (Taipei Hsien, TW) from 2005 to 2011: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 2 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, cardiovascular panel, where it files most

How often FDA has decided Ostar Meditech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ostar Meditech Corp.’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?

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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K112269Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100 for Wrist TypeOstar Meditech Corp. · 2011
  • K050680Blood Pressure Monitor with Spectrum/P2, X2, A2, and K7Ostar Meditech Corp. · 2005

All 2 as Ostar Meditech Corp. →