510(k) · Cleared
Recalled · Class II · 2022EkoSonic Endovascular Device, EKOS+ Endovascular Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · QEY Mechanical Thrombolysis Catheter
Cleared on Dec 14, 2021 as substantially equivalent to K191119 (Btg International, Inc., 2019) and 1 other predicate after a 55-day review. Its family tree reaches back 4 generations to 2014. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 14, 2021
- Review
- 55 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K140151 (2014). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK140151 Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 2014 · Recalled
- 3 generations backK162771 EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 2017 · Recalled
- 2 generations backK183361 EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 2019 · Recalled
- 1 generation backK191119 EkoSonic Endovascular DeviceBtg International, Inc. · 2019
- This deviceK213422 EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation · 2021
- Descendant · cites it directly · 0 of its ownK220866 EKOS+ Endovascular DeviceBoston Scientific · 2022
Most influential descendants
Showing 1 of 1 · See all- K220866EKOS+ Endovascular DeviceBoston Scientific · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit | Btg International, Inc. | 2014 | 3 |
| −3 | K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017 | 1 |
| −2 | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019 | 2 |
| −1 | K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019 | — |
| 0 (this device) | K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021 | — |
| +1 | K220866 | EKOS+ Endovascular Device | Boston Scientific | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K191119 | EkoSonic Endovascular DeviceSummary page 4…Cardiovascular; Class II III. Predicate Devices The proposed modification is to the Indications For Use for both the EkoSonic Endovascular Device (K191119) and EKOS PE Endovascular Device (K200648). The modification to the indications is to include Deep Vein Thrombosis (DVT)… | 2019 |
| * | K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Summary page 4…te Devices The proposed modification is to the Indications For Use for both the EkoSonic Endovascular Device (K191119) and EKOS PE Endovascular Device (K200648). The modification to the indications is to include Deep Vein Thrombosis (DVT). A systematic literature review… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220866 | EKOS+ Endovascular Device | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1491-2022 | Under Investigation by firm | Product may be mislabeled. |
| May 25, 2022 | Class II | Z-1492-2022 | Under Investigation by firm | Product may be mislabeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K220866 (Boston Scientific, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191119.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 EkoSonicm Endovascular System is indicated for the: * Ultrasound facilitated, controlled and selective intravascular infusion ofphysician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis * Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature. The EKOS+ Endovascular System is indicated for the: *…
Read the full statement (96 words)
The EkoSonicm Endovascular System is indicated for the:
* Ultrasound facilitated, controlled and selective intravascular infusion ofphysician-specified fluids, including
thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis
* Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/
or peripheral vasculature.
The EKOS+ Endovascular System is indicated for the:
* Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including
thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis
* Controlled and selective infusion ofphysician-specified fluids, including thrombolytics, into the pulmonary arteries and/
or peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213422: EkoSonic Endovascular Device, EKOS+ Endovascular Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213422
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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