Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Belimed Sauter AG · 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) |
|---|---|---|---|---|---|
| K100622 | BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 | Belimed Sauter AG | 2010-08-27 | 176 | 0 |
| K090339 | BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 | Belimed Sauter AG | 2009-09-23 | 225 | 0 |
| K072087 | BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 | Belimed Sauter AG | 2007-10-05 | 67 | 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