FDA applicant

Elekon Industries U.S.A., Inc.

Plano, TX6 decisions2004–20040 recalls

FDA records 6 decisions for Elekon Industries U.S.A., Inc. (Plano, TX) in 2004: 6 510(k) clearances. Most are in product codes DQA (Oximeter) and DPZ (Oximeter, Ear). Its devices cite 15 predicates, 2 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 Elekon Industries U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elekon Industries U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Elekon Industries U.S.A., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elekon Industries U.S.A., Inc.’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

Elekon Industries U.S.A., Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?