FDA applicant
Xact Robotics, Ltd.
FDA records 4 decisions for Xact Robotics, Ltd. (Caesarea, IL) from 2019 to 2022: 4 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Xact Robotics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Xact Robotics, 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