# K254208: FLOWRUNNER Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Expanse Medical, Inc.
- Decided: Mar 20, 2026 after 81 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: 14 generations back to K003410 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251488: FLOWRUNNER Aspiration System, Expanse Medical, Inc. (2025) Summary page 5.

## Indications for use
The 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/K254208
Methodology: https://510kreport.com/methodology