# K041629: Lysus Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ekos Corp.
- Decided: Aug 6, 2004 after 51 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). 20 ancestors in all.
39 later devices descend from it; 2 cite it directly.
0 of 60 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)
- K974067: Fountain Infusion  Catheter  and Occluding Guide Wire, Merit Medical Systems, Inc. (1998) Summary page 5.
- K991619: FOUNTAIN Infusion Catheter and Occluding Guide Wire, Merit Medical Systems, Inc. (1999) Summary page 5.
- K992231: FOUNTAIN Infusion Catheter and Occluding Guide Wire, Merit Medical Systems, Inc. (1999) Summary page 5.
- K964868: 2.9F Cragg-Mcnamara Valved Infusion Catheter, Micro Therapeutics, Inc. (1997) Summary page 5.
- K033443: Speedlyser Infusion Catheter Kit, AngioDynamics, Inc. (2003) Summary page 5.

## Cited in the summary but kept off the family tree
- K030367: Columbus (PS), Aesculap, Inc. (2003). Our reading of the summary gave K030367, FDA’s number for Columbus (PS) (Aesculap, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EKOS Peripheral Infusion System”. Kept off the family tree. Summary page 5.

## Most influential descendants
- 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
- K060084: Lysus Infusion System (2006), 17 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/K041629
Methodology: https://510kreport.com/methodology