FDA applicant
Visionsense, Ltd.
FDA records 13 decisions for Visionsense, Ltd. (Petach Tikva, Hamerkaz, IL) from 2008 to 2022: 13 510(k) clearances. Most are in product codes OWN (Confocal Optical Imaging) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 180 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 18 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 Visionsense, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
3in 2022
Class I Class II/III not classified
Planning a device like Visionsense, 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