FLOWRUNNER Aspiration System— 510(k) K262864

Name: FDA 510(k) clearance K262864
Creator: U.S. Food and Drug Administration
Published: 2026-10-26

Substantially Equivalent

Expanse Medical, Inc.

FDA 510(k) clearance K262864 for FLOWRUNNER Aspiration System, Substantially Equivalent on 2026-10-26. Applicant: Expanse Medical, Inc.. Device class: 2.

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: 2026-08-14
Decision date: 2026-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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K254208 — FLOWRUNNER Aspiration System2026-03-20

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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.