# K050563: Ekos Peripheral Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Mar 29, 2005 after 25 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904788 (1990). 15 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033214: Ekos Peripheral Infusion System, Ekos Corp. (2003) Summary page 5.

## 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 Peripheral Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K050563
Methodology: https://510kreport.com/methodology