# K081467: Ekosonic Endovascular System with Rapid Pulse Modulation

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Jun 26, 2008 after 30 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K904788 (1990). 47 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080392: EndoWave Infusion System, Ekos Corp. (2008) Summary page 5.
- K073166: Endowave Infusion System, Ekos Corp. (2008) Summary page 5.

## Most influential descendants
- K111705: Ekosonic Endovascular System (2011), 9 descendants of its own
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), 8 descendants of its own
- K192864: UNI*FUSE Infusion System with Cooper Wire (2020), 2 descendants of its own
- K241851: Versus™ Catheter  (VS110-8B) (2024), 1 descendant of its own
- K202347: UNIFUSE Infusion System with Cooper Wire (2020), 1 descendant of its own

## Recalls of this device
- Aug 9, 2016 · Class II · Z-2854-2016: The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters,
- Jan 21, 2016 · Class II · Z-0864-2016: The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family
- Jun 24, 2015 · Class II · Z-2148-2015: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
- Oct 2, 2013 · Class II · Z-0133-2014: The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
- May 24, 2012 · Class II · Z-2023-2012: EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report 

## Indications for use
The EkoSonicTM Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries. The safety and effectiveness of the EKOS EkoSonicTM Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

Source page: https://510kreport.com/device/K081467
Methodology: https://510kreport.com/methodology