Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DSY — Predicate Candidate Screening
188 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
257 days90th percentile
188clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2026-04-27 | 266 | 0 |
| K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | 2025-10-20 | 90 | 0 |
| K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025-02-27 | 272 | 1 |
| K241070 | Gelsoft™ Plus Vascular Prostheses | Vascutek, Ltd. | 2024-11-15 | 210 | 1 |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | 2024-03-28 | 269 | 0 |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-03-01 | 50 | 0 |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular | Peca Labs, Inc. | 2024-01-17 | 51 | 0 |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-01-09 | 160 | 0 |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-12-19 | 46 | 1 |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-06-23 | 30 | 0 |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | 2022-08-15 | 249 | 0 |
| K221628 | exGraft, exGraft Carbon | Peca Labs | 2022-08-04 | 59 | 0 |
| K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | 2021-05-25 | 155 | 0 |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | Vascutek, Ltd. | 2021-04-06 | 202 | 0 |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular | Peca Labs | 2020-12-11 | 105 | 0 |
| K183613 | exGraft, exGraft Carbon | Peca Labs | 2019-04-22 | 117 | 0 |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | 2018-08-21 | 131 | 0 |
| K172637 | HeRO Graft | Merit Medical Systems, Inc. | 2017-11-30 | 90 | 0 |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Pl | Vascutek, Ltd. | 2017-07-14 | 282 | 0 |
| K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017-06-30 | 269 | 0 |
| K153523 | FUSION Vascular Graft | Maquet Cardiovascular, LLC | 2016-02-16 | 69 | 0 |
| K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2015-05-06 | 77 | 0 |
| K142062 | SPIRAL FLOW PERIPHERAL VASCULAR GRAFT | Vascular Flow Technologies, Ltd. | 2014-11-20 | 113 | 0 |
| K141124 | SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT | Vascular Flow Technologies, Ltd. | 2014-05-30 | 29 | 0 |
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT | Maquet Cardiovascular, LLC | 2013-11-14 | 150 | 1 |
| K130215 | GORE ACUSEAL VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2013-04-09 | 70 | 0 |
| K130142 | FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corporation | 2013-03-15 | 52 | 0 |
| K124039 | HERO GRAFT | Hemoshpere, Inc., A Cryolife Company | 2013-03-07 | 69 | 0 |
| K130016 | LIFESPAN EPTFE VASCULAR GRAFT | LeMaitre Vascular, Inc. | 2013-02-05 | 35 | 0 |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corp. | 2012-08-17 | 29 | 1 |
| K121532 | HERO GRAFT | Hemosphere, Inc. | 2012-06-22 | 29 | 0 |
| K120006 | HERO GRAFT | Hemosphere, Inc. | 2012-02-02 | 30 | 0 |
| K113101 | EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL | Boston Scientific Corporation | 2012-01-17 | 90 | 0 |
| K103347 | CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Intervascular Sas | 2011-02-02 | 79 | 0 |
| K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT | Atrium Medical Corp. | 2010-10-05 | 26 | 0 |
| K094044 | SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT | Tayside Flow Technologies Limited | 2010-03-23 | 82 | 0 |
| K093934 | GORE HYBRID VASCULAR GRAFT | W.L. Gore & Associates | 2010-03-17 | 85 | 0 |
| K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | Vascutek, Ltd. | 2010-01-07 | 27 | 0 |
| K092863 | MAXIFLO, TAPERFLO | Vascutek, Ltd. | 2009-10-08 | 21 | 0 |
| K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS | Vascutek, Ltd. | 2009-08-31 | 75 | 0 |
| K091491 | HERO VASCULAR ACCESS DEVICE | Hemosphere, Inc. | 2009-07-31 | 72 | 0 |
| K090987 | VASCUTEK BRANCHED GELWEAVE | Vascutek, Ltd. | 2009-06-19 | 73 | 0 |
| K083169 | EPTFE SLFTM SPIRAL VASCULAR GRAFT | Tayside Flow Technologies Limited | 2009-03-30 | 154 | 0 |
| K071778 | HERO VASCULAR ACCESS DEVICE | Graftcath, Inc. | 2008-01-30 | 212 | 0 |
| K071923 | PTFE FLIXENE GRADUATED WALL GRAFT | Atrium Medical Corp. | 2007-08-14 | 33 | 18 |
| K062161 | GORE PROPATEN VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2006-11-09 | 104 | 0 |
| K061626 | VASORING* VRC VASCULAR RING CONNECTOR | Sunwei Tech Co. , Ltd. | 2006-10-05 | 115 | 0 |
| K060741 | SWIRLGRAFT VASCULAR ACCESS GRAFT | Veryan Medical Limited | 2006-04-05 | 16 | 0 |
| K060124 | ATRIUM FLIXENE GRAFT | Atrium Medical Corp. | 2006-03-30 | 71 | 18 |
| K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RAD | Vascutek, Ltd. | 2006-02-07 | 19 | 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