Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serral, S.A. DE C.V. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
173 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033762 | SERRALAPG | Serral, S.A. DE C.V. | 2004-03-15 | 104 | 0 |
| K020597 | SERRALGUT | Serral, S.A. DE C.V. | 2002-08-14 | 173 | 0 |
| K020902 | SERRALESTER | Serral, S.A. DE C.V. | 2002-05-20 | 61 | 0 |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | 2002-04-26 | 37 | 0 |
| K020146 | SERRALNYL | Serral, S.A. DE C.V. | 2002-04-15 | 89 | 0 |
| K020265 | SERRALENE, MODEL CATALOG NO 1S | Serral, S.A. DE C.V. | 2002-03-08 | 42 | 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