Cleared Special

K254208 - FLOWRUNNER Aspiration System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K254208 · Expanse Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
81d
Days
Class 2
Risk

K254208 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 March 20, 2026 after a review of 81 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Expanse Medical, Inc. devices

Submission Details

510(k) Number K254208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date March 20, 2026
Days to Decision 81 days
Submission Type Special
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
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 91
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K254208.
Liberant™ RX Aspiration Catheter
K253589 · Medtronic Interventional Vascular, Inc. · Apr 2026
Aventus Thrombectomy System
K253925 · Inquis Medical · Jan 2026
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · AngioDynamics, Inc. · Nov 2025
Vesalio Peripheral System
K251312 · Vesalio, Inc. · Oct 2025
FLOWRUNNER Aspiration System
K251488 · Expanse Medical, Inc. · Jul 2025
JETi Hydrodynamic Thrombectomy System
K243549 · Abbott Medical · Apr 2025