FDA applicant
Gradipore, Ltd.
FDA records 4 decisions for Gradipore, Ltd. (Pyrmont, AU) from 1990 to 2000: 4 510(k) clearances. Most are in product codes GIR (Reagent, Russel Viper Venom) and GGC (Control, Plasma, Abnormal). 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
How often FDA has decided Gradipore, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gradipore, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gradipore, 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