FDA applicant
Signostics Pty, Ltd.
FDA records 5 decisions for Signostics Pty, Ltd. (Clovelly Park, AU) from 2009 to 2016: 5 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 15 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Signostics Limited”, “Signostics, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Signostics Pty, 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 2009.
Planning a device like Signostics 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