510(k) · Cleared
Recalled · Class II · 2022EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
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 17, 2020 as substantially equivalent to K183361 (Btg International, Inc., 2019) after a 158-day review. Its family tree reaches back 3 generations to 2014. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2020
- Review
- 158 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K140151 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK140151 Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 2014 · Recalled
- 2 generations backK162771 EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 2017 · Recalled
- 1 generation backK183361 EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 2019 · Recalled
- This deviceK200648 EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation · 2020
- Descendant · cites it directly · 1 of its ownK213422 EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK220866 EKOS+ Endovascular DeviceBoston Scientific · 2022
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 |
|---|---|---|---|---|---|
| −3 | K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit | Btg International, Inc. | 2014 | 3 |
| −2 | K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017 | 1 |
| −1 | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019 | 2 |
| 0 (this device) | K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020 | — |
| +1 | K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021 | 2 |
| +2 | K220866 | EKOS+ Endovascular Device | Boston Scientific | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K183361 | EkoSonic Endovascular Device with Control Unit 4.0Summary page 4…Device with CU4.0 is substantially equivalent to another legally marketed device. This predicate device is the EkoSonic Endovascular Device with CU4.0 (K183361). No reference devices were used in this notification. IV. Device Description The EKOS PE Endovascular S… | 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 |
|---|---|---|---|
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | 2021 | 1 |
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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K213422 (Boston Scientific Corporation, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K183361.
How does its category compare?
All QEY devicesQEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 EKOS PE Endovascular Device with CU 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/K200648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200648: EKOS PE Endovascular Device with Control System 4.0 (CS4.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200648
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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