# K252956: Helo Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Endovascular Engineering, Inc.
- Decided: Dec 18, 2025 after 93 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- 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: 18 generations back to K901627 (1990). 82 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222358: Indigo Aspiration System - Lightning Flash, Penumbra, Inc. (2022) Summary page 5.
- K223891: Cobra Catheter System, Endovascular Engineering (2023) Summary page 5.

## Most influential descendants
- K261800: Helo Max Thrombectomy System (HEL2090) (2026), 0 descendants of its own

## Indications for use
The Hēlo Thrombectomy System is indicated for: • The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature. • The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The Hēlo Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism. The Hēlo Audible Flow Indicator is intended for use exclusively with the Hēlo Thrombectomy System and provides audible feedback of rapid flow through the device during a thrombectomy procedure.

Source page: https://510kreport.com/device/K252956
Methodology: https://510kreport.com/methodology