Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mayo Clinic — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040122 | MAYO CLINIC BC-10 3.0T | Mayo Clinic | 2004-04-14 | 85 | 0 |
| K943230 | MAYO HIP PROSTHESIS | Mayo Clinic | 1997-01-14 | 923 | 0 |
| K852477 | KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS | Mayo Clinic | 1985-07-30 | 49 | 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