Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
SCV · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260804 | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | 2026-07-22 | 132 | 0 |
| K252111 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | 2025-12-16 | 162 | 1 |
| K250725 | Hugo™ RAS System | Covidien, LLC | 2025-12-03 | 268 | 0 |
| DEN230078 | Versius Surgical System | Cmr Surgical Limited | 2024-10-11 | 325 | 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