Cleared Traditional

K262864 - FLOWRUNNER Aspiration System

K262864 is an FDA 510(k) clearance for FLOWRUNNER Aspiration System, manufactured by Expanse Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K262864 · Expanse Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
73d
Days
Class 2
Risk

K262864 is an FDA 510(k) clearance for the FLOWRUNNER Aspiration System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Expanse Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on October 26, 2026 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262864

510(k) Number K262864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2026
Decision Date October 26, 2026
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 95
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K262864.
Mayumi™ Thrombectomy System
K254035 · MicroVention, Inc., d/b/a Terumo Neuro · Sep 2026
Powered Aventus Thrombectomy System™
K261105 · Inquis Medical · Jul 2026
Aventus Thrombectomy System
K262030 · Inquis Medical · Jul 2026
Liberant™ RX Aspiration Catheter
K253589 · Medtronic Interventional Vascular, Inc. · Apr 2026
FLOWRUNNER Aspiration System
K254208 · Expanse Medical, Inc. · Mar 2026
Aventus Thrombectomy System
K253925 · Inquis Medical · Jan 2026
K262864 · FLOWRUNNER Aspiration System
Download PDF FDA Summary Expanse Medical, Inc.