Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sauter AG — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
341 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141879 | BELIMED STEAM STERILIZER MST-H | Sauter AG | 2015-06-17 | 341 | 0 |
| K103841 | BELIMED STEAM STERILIZER MST-V | Sauter AG | 2011-03-15 | 83 | 0 |
| K060337 | BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 | Sauter AG | 2006-03-08 | 26 | 0 |
| K033538 | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 | Sauter AG | 2004-02-02 | 84 | 0 |
| K021223 | BELIMED STEAM STERILIZER, MODEL TOP 5000 | Sauter AG | 2002-06-26 | 69 | 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