FDA applicant
Viasys Healthcare GmbH
FDA records 17 decisions for Viasys Healthcare GmbH (Hoechberg, DE) from 2003 to 2009: 17 510(k) clearances. Most are in product codes BTY (Calculator, Predicted Values, Pulmonary Function) and BZC (Calculator, Pulmonary Function Data). Its devices cite 22 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Viasys Healthcare, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Viasys Healthcare GmbH’s devices, and how often a recall has named them.
FDA decisions per year
4in 2009
2026 so far, outlined.
Recalls per year
2in 2009
Class I Class II/III not classified
Planning a device like Viasys Healthcare GmbH’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) ReportOther applicant names beginning “Viasys”
FDA records each applicant name separately; these may or may not be the same firm.