FDA applicant
Vision Rt, Ltd.
FDA records 11 decisions for Vision Rt, Ltd. (London, GB) from 2006 to 2026: 11 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 10 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Vision RT Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vision Rt, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Vision Rt, 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