# K051225: Ekos Micro-Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Jun 10, 2005 after 29 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: 9 generations back to K904788 (1990). 21 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050563: Ekos Peripheral Infusion System, Ekos Corp. (2005) Summary page 1.
- K041826: Ekos Ultrasound Infusion System, Ekos Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K063620: Ekos Micro-Infusion System (2007), 12 descendants of its own

## Indications for use
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. 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/K051225
Methodology: https://510kreport.com/methodology