Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NTE — Predicate Candidate Screening
36 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
169 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP451 | MicroVention, Inc. | 2023-04-27 | 233 | 0 |
| K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023-04-11 | 55 | 0 |
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli | Cordis Corporation | 2022-04-06 | 30 | 14 |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems, Inc. | 2021-03-03 | 30 | 1 |
| K200198 | WIRION | Cardiovascular Systems, Inc. | 2020-03-18 | 51 | 0 |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter D | Abbott Vascular | 2019-07-25 | 85 | 0 |
| K180023 | WIRION | Gardia Medical , Ltd. | 2018-03-21 | 77 | 0 |
| K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016-03-10 | 98 | 0 |
| K153086 | RX ACCUNET Embolic Protection System | Abbott Vascular | 2015-11-20 | 25 | 0 |
| K143570 | WIRION | Gardia Medical | 2015-06-04 | 169 | 0 |
| K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015-02-09 | 105 | 0 |
| K141678 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | 2014-07-22 | 29 | 0 |
| K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | W. L. Gore & Associates, Inc. | 2012-12-13 | 65 | 0 |
| K121015 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular | 2012-05-04 | 30 | 0 |
| K120480 | GORE(R) EMBOLIC FILTER | W.L. Gore & Associates | 2012-03-16 | 29 | 0 |
| K111010 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2011-10-27 | 199 | 0 |
| K111987 | FIBERNET EMBOLIC PROTECTION DEVICE | Lumen Biomedical, Inc. | 2011-08-17 | 35 | 0 |
| K103500 | GORE EMBOLIC FILTER | W. L. Gore & Associates, Inc. | 2011-05-23 | 175 | 0 |
| K110909 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER D | Abbott Laboratories | 2011-04-29 | 29 | 0 |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI | Cordis Corp. | 2010-07-09 | 28 | 0 |
| K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS01 | Invatec S.P.A. | 2009-10-15 | 86 | 3 |
| K090665 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL | Abbott Vascular-Vascular Solutions | 2009-05-22 | 70 | 0 |
| K083300 | GORE FLOW REVERSAL SYSTEM | W. L. Gore & Associates, Inc. | 2009-02-04 | 86 | 0 |
| K082348 | FIBERNET EMBOLIC PROTECTION SYSTEM | Lumen Biomedical, Inc. | 2008-11-18 | 95 | 2 |
| K081523 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | Abbott Vascular-Vascular Solutions | 2008-09-11 | 101 | 0 |
| K081549 | RX ACCUNET LP EMBOLIC PROTECTION SYSTEM | Abbott Laboratories | 2008-08-19 | 77 | 1 |
| K072990 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID | Medtronic, Inc. | 2007-10-31 | 7 | 0 |
| K063313 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) | Boston Scientific Corp | 2006-12-05 | 33 | 6 |
| K063204 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-11-14 | 22 | 0 |
| K062531 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMB | Cordis Corp., A Johnson & Johnson Co. | 2006-09-22 | 24 | 0 |
| K052659 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-02-17 | 143 | 0 |
| K052454 | THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM | Abbott Vascular Devices | 2005-09-14 | 8 | 0 |
| K052166 | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corporation | 2005-08-18 | 9 | 0 |
| K052165 | RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corporation | 2005-08-16 | 7 | 0 |
| K042908 | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM | Guidant Corp. | 2004-11-12 | 22 | 0 |
| K042218 | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTEC | Guidant Corp. | 2004-08-31 | 26 | 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