510(k) · Cleared
Recalled · Class II · 2016Ekosonic Endovascular System with Rapid Pulse Modulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekos Corp. · QEY Mechanical Thrombolysis Catheter
Cleared on Jun 26, 2008 as substantially equivalent to K080392 (Ekos Corp., 2008) and 1 other predicate after a 30-day review. Its family tree reaches back 16 generations to 1990. 10 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 26, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 16 generations to K904788 (1990). 47 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 12 generations between
- 3 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 2 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 1 generation backK073166 Endowave Infusion SystemEkos Corp. · 2008
- This deviceK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008
- Descendant · cites it directly · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
- Descendant · 2 generations on · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK202347 UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020
Show all 16 generations
- Root · 16 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 15 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 14 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 13 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 12 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 11 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 10 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 9 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 8 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 7 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 6 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 5 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 4 generations backK060084 Lysus Infusion SystemEkos Corp. · 2006
- 3 generations backK062507 Micro-Infusion SystemEkos Corp. · 2006
- 2 generations backK063620 Ekos Micro-Infusion SystemEkos Corp. · 2007
- 1 generation backK073166 Endowave Infusion SystemEkos Corp. · 2008
- This deviceK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · cites it directly9descendants
- K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · 2 generations on8descendants
- K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 3 generations on2descendants
- K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024 · 3 generations on1descendant
- K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −15 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −14 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −13 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −12 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −11 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −10 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −9 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −8 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −7 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −6 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −5 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −4 | K060084 | Lysus Infusion System | Ekos Corp. | 2006 | — |
| −3 | K062507 | Micro-Infusion System | Ekos Corp. | 2006 | — |
| −2 | K063620 | Ekos Micro-Infusion System | Ekos Corp. | 2007 | — |
| −1 | K073166 | Endowave Infusion System | Ekos Corp. | 2008 | — |
| 0 (this device) | K081467 | Ekosonic Endovascular System with Rapid Pulse Modulation | Ekos Corp. | 2008 | — |
| +1 | K111705 | Ekosonic Endovascular System | Ekos Corporation | 2011 | 5 |
| +2 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter… | Thrombolex, Inc. | 2019 | — |
| +3 | K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
| +3 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
| +4 | K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K080392 | EndoWave Infusion SystemSummary page 5…m with Rapid Pulse Modulation Name of Predicate Device: EndoWave Infusion System 510(k) Reference No.: K080392, K073166 Device Description The system consists of a disposable infusion catheter with removable ultrasound core and an instrume… | 2008 |
| * | K073166 | Endowave Infusion SystemSummary page 5…pid Pulse Modulation Name of Predicate Device: EndoWave Infusion System 510(k) Reference No.: K080392, K073166 Device Description The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that g… | 2008 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111705 | Ekosonic Endovascular System | 2011 | 9 |
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 18 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 10 of the 47 ancestors have a recall of any class.
- Of its descendants, K111705 (Ekos Corporation, 2011) has gone furthest, with 9 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. 2008, 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 EkoSonicTM Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.
The safety and effectiveness of the EKOS EkoSonicTM Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081467 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081467: Ekosonic Endovascular System with Rapid Pulse Modulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081467
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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