510(k) · Cleared
ClearedEkoSonic Endovascular Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · QEY Mechanical Thrombolysis Catheter
Cleared on Nov 19, 2021 as substantially equivalent to K191119 (Btg International, Inc., 2019) after a 221-day review. Its family tree reaches back 4 generations to 2014. 2 later devices descend from it.
- Decided
- Nov 19, 2021
- Review
- 221 days
- Class
- Class II
- Product code
- QEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K140151 (2014). 5 ancestors in all. 2 later devices descend 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 deviceK211080 EkoSonic Endovascular DeviceBoston Scientific · 2021
- Descendant · cites it directly · 1 of its ownK222095 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular…Thrombolex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK231653 BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular…Thrombolex, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView 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) | K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021 | — |
| +1 | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter… | Thrombolex, Inc. | 2023 | — |
| +2 | K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter | Thrombolex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K191119 | EkoSonic Endovascular DeviceSummary page 4…Device is substantially equivalent to another legally marketed device. This predicate device is the EkoSonic Endovascular Device (K191119). Device Description The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and EKOS C… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.… | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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 2.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K222095 (Thrombolex, Inc., 2023) has gone furthest, with 1 descendant 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 EkoSonic Endovascular System is indicated for the:
» Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
» Infusion of solutions into the pulmonary arteries.
» Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211080: EkoSonic 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/K211080
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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