FDA applicant

Viasys Respiratory Care, Inc.

Palm Spring, CA3 decisions2006–201119 recalls

FDA records 3 decisions for Viasys Respiratory Care, Inc. (Palm Spring, CA) from 2006 to 2011: 3 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and BZG (Spirometer, Diagnostic). Its devices cite 6 predicates, 0 of them its own earlier devices. 19 recalls are linked to its devices, 13 Class I.

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 Viasys Respiratory Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

12in 2016

2007high 12 (2016) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Viasys Respiratory Care, Inc.’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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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 Medsystems 7 Viasys Neuro Care 2 Viasys Sleep Systems, LLC 1

Viasys Respiratory Care, 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?

What has been recalled?

Other applicant names beginning “Viasys”