Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PQK · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
870 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192239 | WavelinQ Plus EndoAVF System | C.R. Bard, Inc. | 2019-10-17 | 59 | 1 |
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Con | Avenu Medical | 2019-08-09 | 105 | 0 |
| K182796 | WavelinQ 4F EndoAVF System | C.R. Bard, Inc. | 2019-02-06 | 128 | 0 |
| K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Con | Avenu Medical, Inc. | 2019-01-25 | 30 | 0 |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Co | Avenu Medical, Inc. | 2018-10-05 | 98 | 0 |
| DEN170004 | Ellipsys Vascular Access System | Avenu Medical, Inc. | 2018-06-22 | 528 | 0 |
| DEN160006 | everlinQ endoAVF System | Tva Medical, Inc. | 2018-06-22 | 870 | 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