FDA applicant
Unipath, Ltd.
FDA records 73 decisions for Unipath, Ltd. (Bedford Mk41 Oqg, GB) from 1986 to 2006: 73 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and JTN (Susceptibility Test Discs, Antimicrobial). Its devices cite 1 predicate, 0 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 Unipath, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Unipath, Ltd. since 2007.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Unipath, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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