FDA applicant
Optina Diagnostics, Inc.
FDA records 3 decisions for Optina Diagnostics, Inc. (Montreal, CA) from 2020 to 2025: 3 510(k) clearances. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). Since 2016 its 510(k)s took a median of 175 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Optina Diagnostics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Optina Diagnostics, Inc.’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 2020.
Planning a device like Optina Diagnostics, Inc.’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