Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QEY — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
68 daysmedian FDA review time
158 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical, Inc. | 2026-02-17 | 28 | 0 |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | 2026-01-20 | 266 | 0 |
| K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024-11-25 | 151 | 0 |
| K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovas | Thrombolex, Inc. | 2023-07-03 | 27 | 0 |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endov | Thrombolex, Inc. | 2023-04-20 | 276 | 0 |
| K220866 | EKOS+ Endovascular Device | Boston Scientific | 2022-04-20 | 26 | 0 |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021-12-14 | 55 | 0 |
| K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021-11-19 | 221 | 0 |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 End | Thrombolex, Inc. | 2021-06-10 | 62 | 0 |
| K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-09-15 | 28 | 0 |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020-08-17 | 158 | 1 |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-06-01 | 238 | 0 |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019-12-17 | 43 | 0 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2019-10-18 | 28 | 0 |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019-08-23 | 119 | 0 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019-04-05 | 122 | 1 |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovasc | Thrombolex, Inc. | 2019-02-25 | 91 | 0 |
| K182324 | EkoSonic Endovascular System | Btg International, Inc. | 2018-11-26 | 91 | 0 |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion System | AngioDynamics, Inc. | 2017-05-30 | 181 | 1 |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017-02-24 | 144 | 1 |
| K170258 | SpeedLyser Infusion Catheter Kit | AngioDynamics, Inc. | 2017-02-21 | 25 | 0 |
| K162777 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 2016-10-31 | 28 | 0 |
| K153488 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | 2016-02-25 | 83 | 0 |
| K151554 | Occlusion Perfusion Catheter | Advanced Catheter Therapies, Inc. | 2015-09-15 | 98 | 0 |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | Btg International, Inc. | 2014-05-21 | 119 | 2 |
| K130904 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | Covidien | 2013-10-25 | 207 | 2 |
| K111705 | EKOSONIC ENDOVASCULAR SYSTEM | Ekos Corporation | 2011-08-03 | 47 | 4 |
| K083335 | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2008-12-15 | 33 | 0 |
| K082199 | SPIRALFUSE PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2008-10-17 | 74 | 0 |
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | Ekos Corp. | 2008-06-26 | 30 | 4 |
| K080392 | EndoWave Infusion System | Ekos Corp. | 2008-04-30 | 77 | 0 |
| K072507 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2007-10-04 | 28 | 3 |
| K071762 | OMNIWAVE ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2007-09-27 | 90 | 0 |
| K071933 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2007-08-10 | 28 | 0 |
| K063620 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2007-08-06 | 244 | 0 |
| K071664 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2007-07-13 | 25 | 2 |
| K062507 | MICRO-INFUSION SYSTEM | Ekos Corp. | 2006-11-22 | 86 | 0 |
| K060422 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2006-03-09 | 20 | 1 |
| K060084 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2006-02-07 | 27 | 0 |
| K053432 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | 2005-12-30 | 21 | 0 |
| K052428 | RESOLUTION ENDOVASCULAR SYSTEM | Omnisonics Medical Technologies | 2005-12-08 | 97 | 0 |
| K052071 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-08-16 | 15 | 0 |
| K051319 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-06-15 | 26 | 0 |
| K050563 | EKOS PERIPHERAL INFUSION SYSTEM | Ekos Corp. | 2005-03-29 | 25 | 0 |
| K050147 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | 2005-02-03 | 10 | 0 |
| K043269 | Lysus Infusion System | Ekos Corp. | 2004-12-22 | 26 | 0 |
| K042456 | Lysus Infusion System | Ekos Corp. | 2004-09-23 | 13 | 3 |
| K041705 | RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 | Omnisonics Medical Technologies | 2004-09-01 | 70 | 0 |
| K041629 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2004-08-06 | 51 | 0 |
| K041517 | INFUSIONCATH | Id, LLC | 2004-08-05 | 59 | 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