FDA applicant
Menicon Co, Ltd.
FDA records 21 decisions for Menicon Co, Ltd. (Nagoya, JP) from 1989 to 2026: 19 510(k) clearances and 2 original PMA approvals. Most are in product codes MRC (Products, Contact Lens Care, Rigid Gas Permeable) and LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 9 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 Menicon Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Menicon Co, 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) ReportOther applicant names beginning “Menicon”
FDA records each applicant name separately; these may or may not be the same firm.