FDA applicant

Vitaltec Corporation

Taichung City, TW3 decisions2010–20260 recalls

FDA records 3 decisions for Vitaltec Corporation (Taichung City, TW) from 2010 to 2026: 3 510(k) clearances. All are in product code BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 3 predicates, 1 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, anesthesiology panel, where it files most

How often FDA has decided Vitaltec Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Vitaltec Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vitaltec Corporation’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

Vitaltec Corporation

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?