510(k) · Cleared
Recalled · Class II · 2022EkoSonic Endovascular Device with Control Unit 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Btg International, Inc. · QEY Mechanical Thrombolysis Catheter
Cleared on Apr 5, 2019 as substantially equivalent to K162771 (Btg International, Inc., 2017) after a 122-day review. Its family tree reaches back 2 generations to 2014. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 5, 2019
- Review
- 122 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K140151 (2014). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK140151 Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 2014 · Recalled
- 1 generation backK162771 EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 2017 · Recalled
- This deviceK183361 EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK191119 EkoSonic Endovascular DeviceBtg International, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK211080 EkoSonic Endovascular DeviceBoston Scientific · 2021
- Descendant · cites it directly · 2 of its ownK200648 EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK222095 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular…Thrombolex, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK213422 EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation · 2021 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191119EkoSonic Endovascular DeviceBtg International, Inc. · 2019 · cites it directly5descendants
- K211080EkoSonic Endovascular DeviceBoston Scientific · 2021 · 2 generations on2descendants
- K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation · 2020 · cites it directly2descendants
- K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…Thrombolex, Inc. · 2023 · 3 generations on1descendant
- K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit | Btg International, Inc. | 2014 | 3 |
| −1 | K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017 | 1 |
| 0 (this device) | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019 | — |
| +1 | K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019 | — |
| +2 | K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021 | — |
| +1 | K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020 | 1 |
| +3 | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter… | Thrombolex, Inc. | 2023 | — |
| +2 | K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K162771 | EkoSonic Endovascular System with Control Unit 4.0Summary page 5…CU 4.0 (CU 4.0) is substantially equivalent to another legally marketed device. This predicate device is the EKOS EkoSonic Endovascular Device with CU 4.0 (K162771). No reference devices were used in this submission. IV. Device Description The EkoSonic Endovascular Device w… | 2017 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2022 | Class II | Z-0149-2023 | Under Investigation by firm | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. |
| Nov 3, 2020 | Class II | Z-0637-2021 | Device Design | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K191119 (Btg International, Inc., 2019) has gone furthest, with 5 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. 2019, 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 Device with Control Unit 4.0 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/K183361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183361: EkoSonic Endovascular Device with Control Unit 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183361
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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