FDA applicant
Venusa, Ltd.
FDA records 8 decisions for Venusa, Ltd. (Mchenry, IL) from 1981 to 2000: 8 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 4 predicates, 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
How often FDA has decided Venusa, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Venusa, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Venusa, Ltd.’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