FDA applicant
Optik
FDA records 6 decisions for Optik (Criftib, MD) from 1989 to 1994: 6 510(k) clearances. Most are in product codes JEY (Plate, Bone) and HRW (Dynamometer, Nonpowered). 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 Optik’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Optik since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Optik’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