510(k) Report

510(k) · Cleared

Cleared

EkoSonic Endovascular System

K182324510(k) SpecialCleared Nov 26, 201891-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Btg International, Inc. · QEY Mechanical Thrombolysis Catheter

Cleared on Nov 26, 2018 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Nov 26, 2018
Review
91 days
Class
Class II
Product code
QEY
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2021: 2 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared201620182020202220242026
  1. This deviceK182324 EkoSonic Endovascular SystemBtg International, Inc. · 2018
  2. Descendant · cites it directly · 5 of its ownK191119 EkoSonic Endovascular DeviceBtg International, Inc. · 2019
  3. Descendant · 2 generations on · 2 of its ownK211080 EkoSonic Endovascular DeviceBoston Scientific · 2021
  4. Descendant · 3 generations on · 1 of its ownK222095 BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular…Thrombolex, Inc. · 2023
  5. Descendant · 2 generations on · 1 of its ownK213422 EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation · 2021 · Recalled
  6. Descendant · 4 generations on · 0 of its ownK231653 BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular…Thrombolex, Inc. · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019: 12021: 22022: 12023: 2
2019high 2 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K191119EkoSonic Endovascular DeviceBtg International, Inc. · 2019 · cites it directly5descendants
  • K211080EkoSonic Endovascular DeviceBoston Scientific · 2021 · 2 generations on2descendants
  • 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
  • K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K182324EkoSonic Endovascular SystemBtg International, Inc.2018—
+1K191119EkoSonic Endovascular DeviceBtg International, Inc.2019—
+2K211080EkoSonic Endovascular DeviceBoston Scientific2021—
+3K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter…Thrombolex, Inc.2023—
+2K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation20212
+4K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202120
202210
202320
FIG. 1 — Lineage of K182324, 2018–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K191119EkoSonic Endovascular DeviceBtg International, Inc.20195

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?

  • Of its descendants, K191119 (Btg International, Inc., 2019) has gone furthest, with 5 descendants of its own.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · QEY

1in 2024

2007: 52008: 42011: 12013: 12014: 12015: 12016: 22017: 32018: 12019: 52020: 32021: 32022: 12023: 22024: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEY

62in 2021

2007: 28 days median2008: 54 days median2017: 144 days median2019: 91 days median2020: 158 days median2021: 62 days median
2007high 158 (2020) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEY

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QEY

5in 2025

2023: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200752800
200845400
20090—00
20100—00
20111—00
20120—00
20131—00
20141—00
20151—00
20162—00
2017314400
20181—00
201959100
2020315800
202136200
20221—10
20232—11
20241—01
20250—05
20262—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 510(k) statement.

More from Btg International, Inc.

6 FDA decisions under this applicant name. See the company

  • K191119EkoSonic Endovascular DeviceBtg International, Inc. · 2019
  • K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc. · 20192 recalls
  • K172035EKOS ultrasound EVD Device, EVD Control UnitBtg International, Inc. · 2018
  • K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. · 20171 recall
  • K140151Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitBtg International, Inc. · 20143 recalls

Recent decisions in QEY

The QEY category page

  • K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc. · 2026
  • K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc. · 2026
  • K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
  • K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. · 2023
  • K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 2023

https://510kreport.com/device/K182324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182324: EkoSonic Endovascular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182324

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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