Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marian Medical, Inc. — 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) |
|---|---|---|---|---|---|
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | 2007-03-15 | 71 | 0 |
| K063795 | GUARDIANCATHETER-URINARY DRAINAGE CATHETER | Marian Medical, Inc. | 2007-03-05 | 73 | 0 |
| K050542 | MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRA | Marian Medical, Inc. | 2005-07-26 | 146 | 0 |
| K042112 | INFANT FEEDING TUBE | Marian Medical, Inc. | 2005-01-28 | 176 | 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