FDA applicant
CooperVision, Inc.
FDA records 106 decisions for CooperVision, Inc. (Southampton, GB) from 1976 to 2024: 97 510(k) clearances and 9 original PMA approvals. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and HQC (Unit, Phacofragmentation). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 57 predicates, 27 of them its own earlier devices. 23 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided CooperVision, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like CooperVision, 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 “CooperVision”
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