510(k) · Cleared
Recalled · Class II · 2022EkoSonic Endovascular System 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 Feb 24, 2017 as substantially equivalent to K140151 (Btg International, Inc., 2014) after a 144-day review. Its family tree reaches back 1 generation to 2014. 8 later devices descend from it. It has been recalled once.
- Decided
- Feb 24, 2017
- Review
- 144 days
- Class
- Class II
- Product code
- QEY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140151 (2014). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK140151 Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 2014 · Recalled
- This deviceK162771 EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK183361 EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 5 of its ownK191119 EkoSonic Endovascular DeviceBtg International, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK211080 EkoSonic Endovascular DeviceBoston Scientific · 2021
- Descendant · 2 generations on · 2 of its ownK200648 EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation · 2020 · Recalled
- Descendant · 4 generations on · 1 of its ownK222095 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular…Thrombolex, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 2019 · cites it directly7descendants
- K191119EkoSonic Endovascular DeviceBtg International, Inc. · 2019 · 2 generations on5descendants
- K211080EkoSonic Endovascular DeviceBoston Scientific · 2021 · 3 generations on2descendants
- K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation · 2020 · 2 generations on2descendants
- K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…Thrombolex, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control Unit | Btg International, Inc. | 2014 | 3 |
| 0 (this device) | K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | 2017 | — |
| +1 | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019 | 2 |
| +2 | K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019 | — |
| +3 | K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021 | — |
| +2 | K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020 | 1 |
| +4 | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter… | Thrombolex, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitSummary page 4…lly equivalent to another legally marketed device. This predicate device is the EKOS EkoSonic Endovascular System with the EkoSonic Control Unit (PT-3B) (K140151). This predicate device has been subject to one design-related Class II recall. Recall Z-1752-2008 was determine… | 2014 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | 2019 | 7 |
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?
- Its one ancestor has a recall.
- Of its descendants, K183361 (Btg International, Inc., 2019) has gone furthest, with 7 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. 2017, 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 as stated in the FDA summary.
https://510kreport.com/device/K162771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162771: EkoSonic Endovascular System with Control Unit 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162771
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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