# K030637: Ekos Peripheral Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ekos Corp.
- Decided: Jul 22, 2003 after 144 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: 6 generations back to K904788 (1990). 13 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000177: Renegade HI-Flo Microcatheter, Boston Scientific Corp (2000)
- K960806: Turbo Tracker, Target Therapeutics (1996) Summary page 5.
- K926243: Angiographic Catheter, Target Therapeutics (1993) Summary page 5.
- K023514: Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length), Bacchus Vascular, Inc. (2002)
- K950907: Pulse*Spray Infusion System, Angiodynamics, Div. E-Z-Em, Inc. (1995) Summary page 5.

## Cited in the summary but kept off the family tree
- K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300), Endosonics Corp. (1995). Our reading of the summary gave K944004, FDA’s number for Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) (Endosonics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PV 0.018 F/X”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K033214: Ekos Peripheral Infusion System (2003), 46 descendants of its own
- 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

## 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/K030637
Methodology: https://510kreport.com/methodology