FDA applicant
Cyclomedica Australia Pty, Ltd.
FDA records 1 decision for Cyclomedica Australia Pty, Ltd. (Kingsgrove, AU) in 2020: 1 510(k) clearance. All are in product code IYT (System, Rebreathing, Radionuclide). 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 Cyclomedica Australia Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Cyclomedica Australia Pty, 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