Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQJ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101 | Nuwellis, Inc. | 2025-08-13 | 28 | 0 |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (32010 | Nuwellis, Inc. | 2023-12-26 | 55 | 0 |
| K041791 | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2004-09-10 | 70 | 0 |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2003-12-23 | 204 | 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