Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Daum GmbH — 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) |
|---|---|---|---|---|---|
| K010037 | DAUM DOUBLE-SHOOT BISOPSY GUN | Daum GmbH | 2001-03-22 | 77 | 0 |
| K991366 | DAUM MRI/CONVENTIONAL BIOPSY KIT | Daum GmbH | 1999-06-25 | 66 | 0 |
| K990782 | DAUM NEUROGATE TROCAR | Daum GmbH | 1999-04-28 | 50 | 0 |
| K970037 | TARGOGRID | Daum GmbH | 1997-03-12 | 65 | 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