510(k) Report

FDA applicant

Ascendia Medtech AB

Chester, NY1 decision2005–20050 recalls

FDA records 1 decision for Ascendia Medtech AB (Chester, NY) in 2005: 1 510(k) clearance. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). 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, radiology panel, where it files most

How often FDA has decided Ascendia Medtech AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ascendia Medtech AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ascendia Medtech AB’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?

  • ITXTransducer, Ultrasonic, Diagnostic1decision

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?

  • K050320Freescan Latex-Free Ultrasound Transducer Cover KitAscendia Medtech AB · 2005

The one decision as Ascendia Medtech AB →