FLOWRUNNER Aspiration System— 510(k) K254208

Name: FDA 510(k) clearance K254208
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Substantially Equivalent

Expanse Medical, Inc.

FDA 510(k) clearance K254208 for FLOWRUNNER Aspiration System, Substantially Equivalent on 2026-03-20. Applicant: Expanse Medical, Inc.. Device class: 2.

Summary

Expanse Medical's FLOWRUNNER Aspiration System is filed under QEZ, aspiration thrombectomy catheters. The record doesn't list catheter sizes or components.

Class II, 21 CFR 870.5150. It was a Special 510(k), and Cardiovascular is both the classification panel and the review panel.

Expanse Medical filed from Pleasanton, California. The decision came 81 calendar days after FDA received it (December 29, 2025 to March 20, 2026).

Clearance details

Applicant: Expanse Medical, Inc.
Product code: Product code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-12-29
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEZ

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K262864 — FLOWRUNNER Aspiration System2026-10-26
K254035 — Mayumi Thrombectomy System2026-09-03
K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K253589 — Liberant RX Aspiration Catheter2026-04-23

More clearances from Expanse Medical, Inc.

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K251488 — FLOWRUNNER Aspiration System2025-07-14
K234073 — ICE Aspiration System2024-04-19

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.