Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serrano Intl. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
227 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851409 | UNILOC TOTAL HIP PROSTHESIS | Serrano Intl. | 1985-11-22 | 227 | 0 |
| K820619 | MECRON(R) ACETABULAR NETS TM | Serrano Intl. | 1982-05-14 | 67 | 0 |
| K820899 | MECRON VOORHOEVE TITANIUM SHEATH | Serrano Intl. | 1982-05-14 | 44 | 0 |
| K820852 | MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY | Serrano Intl. | 1982-04-15 | 20 | 0 |
| K810497 | BONE FIXACTION SCREW | Serrano Intl. | 1981-03-11 | 15 | 0 |
| K810205 | MECRON CANCELLOUS CANNULATED BONE SCREWS | Serrano Intl. | 1981-02-09 | 14 | 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