FDA applicant
Randox Laboratories, Ltd.
FDA records 134 decisions for Randox Laboratories, Ltd. (Crumlin, GB) from 1992 to 2026: 133 510(k) clearances and 1 De Novo grant. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). Since 2016 its 510(k)s took a median of 492 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 10 of them its own earlier devices. 86 recalls are linked to its devices.
FDA’s records also spell it “Randox Laboratories Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Randox Laboratories, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
6in 2024
Class I Class II/III not classified
Planning a device like Randox Laboratories, 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