FDA applicant
P-Cure, Ltd.
FDA records 4 decisions for P-Cure, Ltd. (Shilat Industrial Zone, IL) from 2010 to 2025: 4 510(k) clearances. Most are in product codes LHN (System, Radiation Therapy, Charged-Particle…) and IYE (Accelerator, Linear, Medical). Its devices cite 4 predicates, 1 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 P-Cure, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like P-Cure, 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