# K041826: Ekos Ultrasound Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ekos Corp.
- Decided: Apr 27, 2005 after 294 days
- Product code: NUI (Ultrasound, Infusion, System)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904788 (1990). 18 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030637: Ekos Peripheral Infusion System, Ekos Corp. (2003) Summary page 1.
- K923368: Magic Infusion Catheter, Target Therapeutics (1993) Summary page 1.
- K023351: Magic Infusion Catheter, Advanced Interventional Technologies, LLC (2003) Summary page 1.
- K000177: Renegade HI-Flo Microcatheter, Boston Scientific Corp (2000)
- K960806: Turbo Tracker, Target Therapeutics (1996) Summary page 1.
- K003105: Biosphere Medical Infusion Catheter, Biosphere Medical (2001) Summary page 1.
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 2.

## Most influential descendants
- K051225: Ekos Micro-Infusion System (2005), 18 descendants of its own
- K053437: Ekos Micro-Infusion System (2006), 16 descendants of its own
- K053432: Ekos Micro-Infusion System (2005), 16 descendants of its own
- K062508: Neurowave Micro-Infusion System (2006), 14 descendants of its own
- K062507: Micro-Infusion System (2006), 13 descendants of its own

## Indications for use
The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

Source page: https://510kreport.com/device/K041826
Methodology: https://510kreport.com/methodology