Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maternus, Inc. — 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) |
|---|---|---|---|---|---|
| K041332 | JOEY CLAMP OPENING TOOL | Maternus, Inc. | 2004-06-25 | 37 | 0 |
| K011621 | KOALA CLAMP, KOALA CLAMP AND CUTTER | Maternus, Inc. | 2001-08-10 | 77 | 0 |
| K010695 | KOALA CLAMP | Maternus, Inc. | 2001-05-03 | 56 | 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