# K200648: EKOS PE Endovascular Device with Control System 4.0 (CS4.0)

- Pathway: 510(k) (Special)
- Applicant: Ekos Corporation
- Decided: Aug 17, 2020 after 158 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K140151 (2014). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183361: EkoSonic Endovascular Device with Control Unit 4.0, Btg International, Inc. (2019) Summary page 4.

## Most influential descendants
- K213422: EkoSonic Endovascular Device, EKOS+ Endovascular Device (2021), 1 descendant of its own
- K220866: EKOS+ Endovascular Device (2022), 0 descendants of its own

## Recalls of this device
- Oct 13, 2022 · Class II · Z-0149-2023: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.

## Indications for use
The EKOS PE Endovascular Device with CU 4.0 is indicated for the: » Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. » Infusion of solutions into the pulmonary arteries. » Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Source page: https://510kreport.com/device/K200648
Methodology: https://510kreport.com/methodology