# K052071: Lysus Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Aug 16, 2005 after 15 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: 11 generations back to K904788 (1990). 23 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051319: Lysus Infusion System, Ekos Corp. (2005) Summary page 5.

## Most influential descendants
- K060422: Lysus Infusion System (2006), 27 descendants of its own
- K060084: Lysus Infusion System (2006), 17 descendants of its own
- K062508: Neurowave Micro-Infusion System (2006), 14 descendants of its own
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (2016), 13 descendants of its own
- K072507: Endowave Infusion System (2007), 13 descendants of its own

## Indications for use
The Lysus® 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/K052071
Methodology: https://510kreport.com/methodology