Cleared Traditional

K240426 - Aventus Clot Management System (FDA 510(k) Clearance)

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

K240426 · Inquis Medical · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 194
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