FDA applicant
Contamac, Ltd.
FDA records 19 decisions for Contamac, Ltd. (Saffron Walden, GB) from 2002 to 2026: 18 510(k) clearances and 1 original PMA approval. Most are in product codes HQD (Lens, Contact (Other Material) - Daily) and LPL (Lenses, Soft Contact, Daily Wear). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 53 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 8 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Contamac, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Contamac, 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) Report