Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fournitures Hospitalieres · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021109 | ESOP CO-CR FEMORAL HEADS | Fournitures Hospitalieres | 2002-06-12 | 68 | 0 |
| K021108 | ESOP HA FEMORAL STEM | Fournitures Hospitalieres | 2002-05-03 | 28 | 0 |
| K964878 | ESOP S/C FEMORAL STEM | Fournitures Hospitalieres | 1998-03-05 | 455 | 0 |
| K961388 | ATLAS III ACETABULAR CUP | Fournitures Hospitalieres | 1997-04-03 | 358 | 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