510(k) · Cleared
Recalled · Class II · 2016Ekosonic Endovascular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekos Corporation · QEY Mechanical Thrombolysis Catheter
Cleared on Aug 3, 2011 as substantially equivalent to K081467 (Ekos Corp., 2008) after a 47-day review. Its family tree reaches back 17 generations to 1990. 9 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 3, 2011
- Review
- 47 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 17 generations to K904788 (1990). 48 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 13 generations between
- 3 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 2 generations backK073166 Endowave Infusion SystemEkos Corp. · 2008
- 1 generation backK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- This deviceK111705 Ekosonic Endovascular SystemEkos Corporation · 2011
- Descendant · cites it directly · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK202347 UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK193071 Bashir Plus Endovascular CatheterThrombolex, Inc. · 2019
Show all 17 generations
- Root · 17 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 16 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 15 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 14 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 13 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 12 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 11 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 10 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 9 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 8 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 7 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 6 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 5 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 4 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 3 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 2 generations backK073166 Endowave Infusion SystemEkos Corp. · 2008
- 1 generation backK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
- This deviceK111705 Ekosonic Endovascular SystemEkos Corporation · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · cites it directly8descendants
- K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 2 generations on2descendants
- K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024 · 2 generations on1descendant
- K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 3 generations on1descendant
- K193071Bashir Plus Endovascular CatheterThrombolex, Inc. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −16 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −15 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −14 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −13 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −12 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −11 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −10 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −9 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −8 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −7 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −6 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −5 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −4 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| −3 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| −2 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| −1 | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | 5 |
| 0 (this device) | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | — |
| +1 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| +2 | K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
| +2 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
| +3 | K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
| +2 | K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEY device
- #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081467 | Ekosonic Endovascular System with Rapid Pulse ModulationSummary page 5…another legally marketed device. These devices include 1. EKOS EkoSonic Endovascular System (EKOS Corporation, K(081467) Performance: EKOS has conducted preclinical bench and animal studies with the EkoSonic Endovascu… | 2008 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | 2019 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2016 | Class II | Z-2854-2016 | Storage | The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister… |
| Jan 21, 2016 | Class II | Z-0864-2016 | Error in labeling | The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working… |
| Jun 24, 2015 | Class II | Z-2148-2015 | Vendor change control | The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. |
| Oct 2, 2013 | Class II | Z-0133-2014 | Mixed-up of materials/components | The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference. |
| May 24, 2012 | Class II | Z-2023-2012 | Device Design | EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 11 of the 48 ancestors have a recall of any class.
- Of its descendants, K183290 (Thrombolex, Inc., 2019) has gone furthest, with 8 descendants of its own.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · QEY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QEY
62in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEY
5in 2025
MAUDE reports naming product code QEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 28 | 0 | 0 |
| 2008 | 4 | 54 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | 144 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 5 | 91 | 0 | 0 |
| 2020 | 3 | 158 | 0 | 0 |
| 2021 | 3 | 62 | 0 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111705: Ekosonic Endovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111705
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026