FDA applicant
Nidek, Inc.
FDA records 100 decisions for Nidek, Inc. (Palo Alto, CA) from 1983 to 2023: 98 510(k) clearances and 2 original PMA approvals. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 70 predicates, 26 of them its own earlier devices. 14 recalls are linked to its devices.
FDA’s records also spell it “Nidek Co., Ltd.”, “Nidek Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nidek, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Nidek, 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) ReportOther applicant names beginning “Nidek”
FDA records each applicant name separately; these may or may not be the same firm.