FDA applicant
Oventus Manufacturing Pty, Ltd.
FDA records 4 decisions for Oventus Manufacturing Pty, Ltd. (Indooroopilly, AU) from 2016 to 2019: 4 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 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 Oventus Manufacturing Pty, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Oventus Manufacturing 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