510(k) Report

FDA applicant

Comdek Industrial Corp.

Taipei, TW1 decision2009–20090 recalls

FDA records 1 decision for Comdek Industrial Corp. (Taipei, TW) in 2009: 1 510(k) clearance. All are in product code DQA (Oximeter). 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 Comdek Industrial Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Comdek Industrial Corp. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Comdek Industrial 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?

  • DQAOximeter1decision

What has FDA decided for it lately?

  • K083351Proable Pulse Oximeter, Model MD-600P, Traveler Oximeter, Model MD-650P and Palm Pulse Oximeter, Model MD-680PComdek Industrial Corp. · 2009

The one decision as Comdek Industrial Corp. →