# K062508: Neurowave Micro-Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Dec 5, 2006 after 99 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: 13 generations back to K904788 (1990). 34 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060084: Lysus Infusion System, Ekos Corp. (2006) Summary page 1.
- K053437: Ekos Micro-Infusion System, Ekos Corp. (2006) Summary page 1.
- K053432: Ekos Micro-Infusion System, Ekos Corp. (2005) Summary page 1.

## Most influential descendants
- K063620: Ekos Micro-Infusion System (2007), 12 descendants of its own
- K080392: EndoWave Infusion System (2008), 11 descendants of its own
- K073166: Endowave Infusion System (2008), 11 descendants of its own
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation (2008), 10 descendants of its own
- K111705: Ekosonic Endovascular System (2011), 9 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/K062508
Methodology: https://510kreport.com/methodology