Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Manfred Sauer Corp. — 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) |
|---|---|---|---|---|---|
| K812249 | SKIN ADHESIVE-50XX | Manfred Sauer Corp. | 1981-09-23 | 43 | 0 |
| K812252 | LATEX LEG BAG-57.XX | Manfred Sauer Corp. | 1981-08-20 | 9 | 0 |
| K812251 | DISPOSABLE URINE GAB-70.XX | Manfred Sauer Corp. | 1981-08-20 | 9 | 0 |
| K812250 | CONDOM-52.XX | Manfred Sauer Corp. | 1981-08-20 | 9 | 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