Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QEZ — Predicate Candidate Screening
94 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
177 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261105 | Powered Aventus Thrombectomy System™ | Inquis Medical | 2026-07-27 | 115 | 0 |
| K262030 | Aventus Thrombectomy System | Inquis Medical | 2026-07-15 | 28 | 0 |
| K253589 | Liberant™ RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | 2026-04-23 | 157 | 0 |
| K254208 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2026-03-20 | 81 | 0 |
| K253925 | Aventus Thrombectomy System | Inquis Medical | 2026-01-15 | 38 | 0 |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | AngioDynamics, Inc. | 2025-11-24 | 108 | 0 |
| K251312 | Vesalio Peripheral System | Vesalio, Inc. | 2025-10-24 | 179 | 0 |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | 2025-07-14 | 61 | 0 |
| K243549 | JETi Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | 2025-04-04 | 140 | 0 |
| K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60 | Control Medical Technology, Inc. / Dba Ventiv Scientific | 2025-03-24 | 81 | 0 |
| K240397 | AlphaVac MMA F1885 System (H787253020) | AngioDynamics, Inc. | 2024-04-01 | 52 | 0 |
| K232458 | JETi™Hydrodynamic Thrombectomy System | ABBOTT MEDICAL | 2023-12-19 | 126 | 0 |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 Syst | AngioDynamics, Inc. | 2022-04-04 | 172 | 0 |
| K213565 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2022-02-01 | 84 | 0 |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2021-11-03 | 112 | 0 |
| K213166 | Thrombuster II Aspiration Catheter | Kaneka Medical America, LLC | 2021-10-26 | 28 | 0 |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | AngioDynamics, Inc. | 2021-06-04 | 53 | 0 |
| K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | 2020-11-17 | 120 | 0 |
| K200871 | Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire | Control Medical Technology | 2020-05-04 | 33 | 0 |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | 2020-04-20 | 152 | 0 |
| K192439 | JETi Peripheral Thrombectomy System | Walk Vascular, LLC | 2019-12-09 | 94 | 0 |
| K190619 | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | 2019-04-29 | 49 | 0 |
| K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | 2019-04-17 | 131 | 0 |
| K182232 | Octane Mechanical Thrombectomy System | Vascular Solutions, Inc. | 2018-09-11 | 25 | 0 |
| K173266 | Octane aspiration system | Vascular Solutions, Inc. | 2017-12-01 | 51 | 0 |
| K172000 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017-10-24 | 113 | 0 |
| K163051 | ClearLumen II Peripheral Thrombectomy System | Walk Vascular, LLC | 2017-02-21 | 112 | 0 |
| K161786 | ClearLumen II Thrombectomy System | Walk Vascular, LLC | 2016-10-18 | 111 | 0 |
| K140296 | CLEARLUMEN THROMBECTOMY SYSTEM | Walk Vascular, LLC | 2014-12-02 | 299 | 0 |
| K131998 | ASPIRE RX-LP6 ASPIRATION CATHETER | Control Medical Technology, LLC | 2013-11-26 | 151 | 0 |
| K132155 | Merit ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | 2013-11-07 | 118 | 0 |
| K130536 | EXPORT ADVANCE ASPIRATION CATHETER | Medtronic, Inc. | 2013-07-16 | 137 | 0 |
| K123482 | REFLOW ASPIRATION CATHETER | Volcano Corporation | 2013-04-29 | 167 | 0 |
| K120508 | CLEARLUMEN THROMBECTOMY SYSTEM | Walk Vascular, LLC | 2012-11-07 | 260 | 0 |
| K121301 | XPRESSWAY RX CATHETER (6F LD-VERISON) | Kaneka Pharma America, LLC | 2012-07-30 | 90 | 0 |
| K120808 | EXPORT XT CATHETER, EXPORT AP CATHETER | Medtronic, Inc. | 2012-06-07 | 83 | 0 |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | Medrad, Inc. | 2012-06-06 | 204 | 1 |
| K113757 | ASPIRE MAX ASPIRATION CATHETER | Control Medical Technology, LLC | 2012-02-22 | 63 | 0 |
| K112382 | TERUMO ASPRIATION CATHETER | Terumo Medical Corporation | 2011-12-14 | 118 | 0 |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | Medrad, Inc. | 2011-12-02 | 11 | 0 |
| K110315 | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE | Nexgen Medical Systems, Inc. | 2011-10-20 | 260 | 0 |
| K112571 | XL EXTRACTION CATHETER | Vascular Solutions, Inc. | 2011-10-06 | 30 | 0 |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | Medrad, Inc. | 2011-05-24 | 27 | 1 |
| K100569 | MERIT EMBOLECTOMY CATHETER MODEL ASAP100 | Merit Medical Systems, Inc. | 2011-03-11 | 375 | 0 |
| K101354 | FETCH 2 ASPIRATION CATHETER MODEL 109400-001 | Medrad Interventional/Possis | 2011-01-21 | 252 | 1 |
| K103405 | PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CAT | Vascular Solutions, Inc. | 2010-12-22 | 33 | 1 |
| K101839 | KANEKA PHARMA AMERICA XPRESS-WAY RX | Kaneka Pharma America, LLC | 2010-10-22 | 113 | 0 |
| K101406 | ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 | Medrad Interventional/Possis | 2010-06-16 | 28 | 0 |
| K091703 | HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, | Concentric Medical, Inc. | 2009-10-14 | 126 | 0 |
| K091593 | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS | Possis Medical, Inc. | 2009-06-22 | 20 | 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