# K033214: Ekos Peripheral Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Oct 14, 2003 after 11 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: 7 generations back to K904788 (1990). 14 ancestors in all.
46 later devices descend from it; 2 cite it directly.
0 of 61 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)

## Most influential descendants
- K041629: Lysus Infusion System (2004), 39 descendants of its own
- K042456: Lysus Infusion System (2004), 38 descendants of its own
- K051319: Lysus Infusion System (2005), 35 descendants of its own
- K052071: Lysus Infusion System (2005), 34 descendants of its own
- K060422: Lysus Infusion System (2006), 27 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/K033214
Methodology: https://510kreport.com/methodology