Cleared Traditional

K253925 - Aventus Thrombectomy System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253925 · Inquis Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
38d
Days
Class 2
Risk

K253925 is an FDA 510(k) clearance for the Aventus Thrombectomy System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on January 15, 2026 after a review of 38 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.

View all Inquis Medical devices

Submission Details

510(k) Number K253925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2025
Decision Date January 15, 2026
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K253925.
Liberant™ RX Aspiration Catheter
K253589 · Medtronic Interventional Vascular, Inc. · Apr 2026
FLOWRUNNER Aspiration System
K254208 · Expanse Medical, Inc. · Mar 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