Ekos Corp.
Bothell, WA, US
Ekos Corp. appears in FDA device records in Bothell, WA. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Ekos Corp. between 2003 and 2020. The busiest year on record is 2005, with 7. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 7 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 3 |
| 2011 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | QEY | Substantially Equivalent | |
| K111705 | EKOSONIC ENDOVASCULAR SYSTEM | QEY | Substantially Equivalent | |
| K081467 | EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION | QEY | Substantially Equivalent | |
| K080392 | EndoWave Infusion System | QEY | Substantially Equivalent | |
| K073166 | ENDOWAVE INFUSION SYSTEM | KRA | Unknown | |
| K072507 | ENDOWAVE INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K071933 | ENDOWAVE INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K063620 | EKOS MICRO-INFUSION SYSTEM | QEY | Unknown | |
| K062508 | NEUROWAVE MICRO-INFUSION SYSTEM | NUI | Unknown | |
| K062507 | MICRO-INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K060422 | LYSUS INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K060084 | LYSUS INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K053437 | EKOS MICRO-INFUSION SYSTEM | NUI | Substantially Equivalent | |
| K053432 | EKOS MICRO-INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K052071 | LYSUS INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K051319 | LYSUS INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K051225 | EKOS MICRO-INFUSION SYSTEM | NUI | Unknown | |
| K041826 | EKOS ULTRASOUND INFUSION SYSTEM | NUI | Unknown | |
| K050563 | EKOS PERIPHERAL INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K050472 | LYSUS INFUSION SYSTEM | DRA | Substantially Equivalent | |
| K043269 | Lysus Infusion System | QEY | Substantially Equivalent | |
| K042456 | Lysus Infusion System | QEY | Substantially Equivalent | |
| K041629 | LYSUS INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K033214 | EKOS PERIPHERAL INFUSION SYSTEM | QEY | Substantially Equivalent | |
| K030637 | EKOS PERIPHERAL INFUSION SYSTEM | QEY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2890-2016 | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking. | Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure. | Class II | Terminated | |
| Z-2854-2016 | EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter | 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, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device. | Class II | Terminated | |
| Z-0864-2016 | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. | 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 code, however the MSD actual working length is 106 cm. | Class II | Terminated | |
| Z-2148-2015 | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. | The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. | Class II | Terminated | |
| Z-0133-2014 | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. | 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. | Class II | Terminated | |
| Z-2023-2012 | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries. | 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 of MicroSonic Device (MSD) breaking during insertion or operation. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain