FDA applicant

Viasys Medsystems

Wheeling, IL7 decisions2004–20082 recalls

FDA records 7 decisions for Viasys Medsystems (Wheeling, IL) from 2004 to 2008: 7 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FYA (Gown, Surgical). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2008

2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Viasys Medsystems’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

Other applicant names beginning “Viasys”

FDA records each applicant name separately; these may or may not be the same firm.

Viasys Healthcare GmbH 17 Viasys Respiratory Care, Inc. 3 Viasys Neuro Care 2 Viasys Sleep Systems, LLC 1

Viasys Medsystems

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Viasys”