Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DYF — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
190 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | Impra, Inc. | 2001-05-14 | 138 | 0 |
| K000504 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | 2000-03-01 | 15 | 1 |
| K992958 | ADVANTA GRAFT (<6MM) | Atrium Medical Corp. | 1999-10-01 | 29 | 15 |
| K991683 | PTFE RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1999-09-08 | 114 | 0 |
| K992441 | ADVANTA GRAFT | Atrium Medical Corp. | 1999-08-20 | 29 | 1 |
| K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | Possis Medical, Inc. | 1999-02-01 | 70 | 0 |
| K983769 | DISTAFLO BYPASS GRAFT | Impra, Inc. | 1998-12-15 | 50 | 0 |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENA | Impra, Inc. | 1998-05-07 | 44 | 0 |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Impra, Inc. | 1997-03-20 | 105 | 0 |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 | 387 | 0 |
| K955533 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1996-05-15 | 162 | 0 |
| K953287 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1995-10-06 | 85 | 0 |
| K944844 | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT | Baxter Healthcare Corp | 1995-03-31 | 182 | 0 |
| K933391 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | 1994-12-15 | 521 | 0 |
| K940824 | DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III | W. L. Gore & Associates, Inc. | 1994-05-04 | 118 | 0 |
| K934726 | FEP RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1993-12-08 | 68 | 0 |
| K924360 | IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) | Impra, Inc. | 1992-11-25 | 89 | 0 |
| K881732 | GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1988-05-18 | 26 | 0 |
| K842144 | GORE-TEX VASCULAR GRAFT, FEP-RINGED | W. L. Gore & Associates, Inc. | 1984-10-01 | 124 | 0 |
| K821826 | FEP-RINGED GORE-TEX@ VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1982-12-29 | 190 | 0 |
| K791810 | VASCULAR GRAFT PROST. OF EXPANDED PTFE | Impra, Inc. | 1979-10-09 | 25 | 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