# K042456: Lysus Infusion System

- Pathway: 510(k) (Special)
- Applicant: Ekos Corp.
- Decided: Sep 23, 2004 after 13 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904788 (1990). 21 ancestors in all.
38 later devices descend from it; 3 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)
- K041629: Lysus Infusion System, Ekos Corp. (2004) Summary page 5.

## Most influential descendants
- 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
- K062508: Neurowave Micro-Infusion System (2006), 14 descendants of its own

## Recalls of this device
- Jan 18, 2005 · Not classified · Z-0175-06: Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
- Nov 22, 2004 · Not classified · Z-0111-06: During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aor
- Sep 21, 2004 · Not classified · Z-0110-06: The 100V board in the catheter interface cable pod failed during use. The PT-3 control unit would not recognize the catheter interface cable.

## 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/K042456
Methodology: https://510kreport.com/methodology