Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sodem Diffusion SA — 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) |
|---|---|---|---|---|---|
| K954717 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY | Sodem Diffusion SA | 1997-01-22 | 467 | 0 |
| K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOM | Sodem Diffusion SA | 1996-01-22 | 70 | 0 |
| K954080 | SODEM HIGH SPEED SYSTEM | Sodem Diffusion SA | 1995-10-16 | 46 | 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