Cleared Traditional

K240426 - Aventus Clot Management System

K240426 is an FDA 510(k) clearance for Aventus Clot Management System, manufactured by Inquis Medical. The device is a Class 2 Cardiovascular device with product code CAC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K240426 · Inquis Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
91d
Days
Class 2
Risk

K240426 is an FDA 510(k) clearance for the Aventus Clot Management System. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Inquis Medical (Menlo Park, US). The FDA issued a Cleared decision on May 14, 2024 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 868.5830 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Inquis Medical devices

FDA 510(k) Submission Details - K240426

510(k) Number K240426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2024
Decision Date May 14, 2024
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 - CAC Apparatus, Autotransfusion

All 137
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K240426.
XTRA Collection sets
K241236 · Sorin Group Italia S.R.L. · Aug 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · Sorin Group Italia S.R.L. · Apr 2024
FlowSaver Blood Return System (80-101)
K231782 · Inari Medical, Inc. · Jul 2023
FlowSaver Blood Return System
K221483 · Inari Medical, Inc. · Feb 2023
Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
K221722 · Haemonetics Corporation · Nov 2022
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
K201305 · Atrium Medical Corporation · Sep 2021