Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
P-Cure, Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | 2025-05-12 | 270 | 0 |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023-03-20 | 257 | 0 |
| K160611 | P-ARTIS | P-Cure, Ltd. | 2016-08-08 | 158 | 0 |
| K092424 | P-ART, MODEL 001 | P-Cure, Ltd. | 2010-03-05 | 210 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda