FDA applicant
Precision AI Pty, Ltd.
FDA records 3 decisions for Precision AI Pty, Ltd. (Fortitude Valley, AU) from 2024 to 2026: 3 510(k) clearances. All are in product code QHE (Shoulder Arthroplasty Implantation System). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 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 Precision AI Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Precision AI 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