Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QHW · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251831 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2026-01-15 | 216 | 0 |
| K240534 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2024-04-19 | 53 | 0 |
| K201057 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2022-01-14 | 633 | 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