FDA applicant
Analytica, Ltd.
FDA records 3 decisions for Analytica, Ltd. (Brisbane, AU) from 2010 to 2016: 3 510(k) clearances. Most are in product codes HIR (Perineometer) and FPA (Set, Administration, Intravascular). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Analytica Pty, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Analytica, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Analytica, 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