Is this your brand? Sign in to claim ownership.

Ekos Corporation

Last updated May 30, 2026

What Ekos Corporation makes

Ekos Corporation manufactures ultrasound thrombolysis systems, including control units designed to facilitate the dissolution of blood clots within blood vessels. Their portfolio includes integrated endovascular systems and standalone control units, such as the EkoSonic® and EKOS PE Endovascular Device with Control System 4.0 (CS4.0), which combine mechanical and ultrasound-based thrombolysis for vascular applications.

The company’s devices are classified as Class II under regulatory frameworks, with authorisations granted through FDA 510(k) clearances and FDA Unique Device Identification (UDI) listings. These products are intended for use in endovascular procedures and are governed by the same compliance standards as other Class II medical devices in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Ekos Corporation manufacture?

Ekos Corporation specializes in ultrasound thrombolysis systems, which are designed to help dissolve blood clots within blood vessels. Their primary product category is the ultrasound thrombolysis system control unit, often integrated with endovascular devices like the EkoSonic® or EKOS PE Endovascular Device with Control System 4.0 (CS4.0). These systems combine ultrasound energy with mechanical methods to treat vascular clots, such as those in peripheral arteries or the pulmonary embolism (PE) setting.

Where is Ekos Corporation based, and what does that mean for its regulatory oversight?

Ekos Corporation is based in the United States, which means its devices are subject to FDA (U.S. Food and Drug Administration) regulatory oversight. Since the company’s products fall under Class II classification, they require pre-market clearance via the FDA’s 510(k) pathway or compliance with Unique Device Identification (UDI) requirements. This classification indicates moderate regulatory scrutiny due to the devices’ intended use in endovascular procedures, where safety and effectiveness are critical.

Which regulatory registries or databases list Ekos Corporation’s devices?

Ekos Corporation’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identification (UDI) database. These registries document the pre-market clearance process and compliance with UDI requirements, ensuring traceability and transparency for healthcare providers and regulators. The inclusion in these databases reflects the company’s adherence to FDA standards for Class II medical devices.

How are Ekos Corporation’s devices classified under regulatory frameworks?

Ekos Corporation’s devices are classified as Class II under U.S. regulatory frameworks. This classification is determined by the FDA based on the risk associated with the device’s intended use—here, ultrasound thrombolysis for vascular applications. Class II devices require special controls beyond general controls (like good manufacturing practices) to ensure safety and performance, often involving pre-market notifications (510(k)) or post-market surveillance. The classification ensures these devices meet rigorous standards before entering the market.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: ekoscorp.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 888-400-3567
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 943488429

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
EkoSonic®	700-10302	FDA UDI	Class II	Active
EkoSonic®	600-30000	FDA UDI	Class II	Active
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)	K200648	FDA 510(k)	Class II	Active
Lysus Infusion System	K042456	FDA 510(k)	Class II	Active
Lysus Infusion System	K060084	FDA 510(k)	Class II	Active
Ekos Ultrasound Infusion System	K041826	FDA 510(k)	Class II	Active
Ekosonic Endovascular System With Rapid Pulse Modulation	K081467	FDA 510(k)	Class II	Active
Endowave Infusion System	K072507	FDA 510(k)	Class II	Active
Lysus Infusion System	K060422	FDA 510(k)	Class II	Active
Lysus Infusion System	K043269	FDA 510(k)	Class II	Active
Endowave Infusion System	K071933	FDA 510(k)	Class II	Active
Lysus Infusion System	K041629	FDA 510(k)	Class II	Active
Ekos Micro-Infusion System	K051225	FDA 510(k)	Class II	Active
Neurowave Micro-Infusion System	K062508	FDA 510(k)	Class II	Active
Endowave Infusion System	K073166	FDA 510(k)	Class II	Active
Ekos Micro-Infusion System	K053437	FDA 510(k)	Class II	Active
Lysus Infusion System	K051319	FDA 510(k)	Class II	Active
Ekos Peripheral Infusion System	K033214	FDA 510(k)	Class II	Active
Ekos Peripheral Infusion System	K030637	FDA 510(k)	Class II	Active
Ekos Peripheral Infusion System	K050563	FDA 510(k)	Class II	Active
Ekos Micro-Infusion System	K063620	FDA 510(k)	Class II	Active
Lysus Infusion System	K052071	FDA 510(k)	Class II	Active
Micro-Infusion System	K062507	FDA 510(k)	Class II	Active
EndoWave Infusion System	K080392	FDA 510(k)	Class II	Active
Ekos Micro-Infusion System	K053432	FDA 510(k)	Class II	Active
Lysus Infusion System	K050472	FDA 510(k)	Class II	Active
Ekosonic Endovascular System	K111705	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Ekos Corporation has 14 FDA recall records initiated between September 21, 2004, and August 22, 2016, all marked as terminated. The recalls involve issues such as mechanical failures (e.g., missing washers on carts, dislodged radio-opaque markers, catheter disconnections), electrical malfunctions (e.g., potential burn risk, control unit recognition failures, power module defects), labeling inaccuracies (e.g., incorrect working lengths, mislabeled treatment zones), and design or assembly shortcomings (e.g., missing caution labels, non-compliant manufacturing tests, improperly installed components).

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Aug 22, 2016	Z-2890-2016	—	terminated	Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Aug 9, 2016	Z-2854-2016	—	terminated	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.
Jan 21, 2016	Z-0864-2016	—	terminated	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.
Jun 24, 2015	Z-2148-2015	—	terminated	The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
Oct 2, 2013	Z-0133-2014	—	terminated	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	Z-2023-2012	—	terminated	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.
Apr 1, 2008	Z-1773-2008	—	terminated	Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.
Mar 10, 2008	Z-1752-2008	—	terminated	Potential for unit to burn patient.
Feb 20, 2008	Z-1892-2008	—	terminated	Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone.
Feb 9, 2007	Z-0577-2007	—	terminated	Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.
Oct 12, 2006	Z-0195-2007	—	terminated	Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
Jan 18, 2005	Z-0175-06	—	terminated	Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
Nov 22, 2004	Z-0111-06	—	terminated	During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered
Sep 21, 2004	Z-0110-06	—	terminated	The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.