FDA applicant
Optimum Manufacturers, Inc.
FDA records 3 decisions for Optimum Manufacturers, Inc. (Walker, MI) in 1984: 3 510(k) clearances. Most are in product codes LRX (Case, Contact Lens) and HQD (Lens, Contact (Other Material) - Daily). 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 Optimum Manufacturers, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Optimum Manufacturers, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Optimum Manufacturers, 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