# K251488: FLOWRUNNER Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Expanse Medical, Inc.
- Decided: Jul 14, 2025 after 61 days
- Product code: QEZ (Aspiration Thrombectomy 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: 13 generations back to K003410 (2001). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234073: ICE Aspiration System, Expanse Medical, Inc. (2024) Summary page 5.

## Most influential descendants
- K254208: FLOWRUNNER Aspiration System (2026), 0 descendants of its own

## Indications for use
The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Source page: https://510kreport.com/device/K251488
Methodology: https://510kreport.com/methodology