Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fixano SA — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
87 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023314 | MICROFIX | Fixano SA | 2002-10-18 | 45 | 0 |
| K022771 | TWIN FIX | Fixano SA | 2002-09-23 | 33 | 0 |
| K012062 | PF2 | Fixano SA | 2001-09-27 | 87 | 0 |
| K012078 | RADIOFIX | Fixano SA | 2001-09-27 | 87 | 0 |
| K012161 | FLEX-NAILS | Fixano SA | 2001-08-24 | 44 | 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