Cleared Special

K250150 - VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set) (FDA 510(k) Clearance)

Also includes:
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt) VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

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

K250150 · Sorin Group Italia S.R.L. · Cardiovascular device
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May 2025
Decision
129d
Days
Class 2
Risk

K250150 is an FDA 510(k) clearance for the VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set). Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on May 30, 2025 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sorin Group Italia S.R.L. devices

Submission Details

510(k) Number K250150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2025
Decision Date May 30, 2025
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 90
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K250150.
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
K252541 · Spectrum Medical S.R.L. · Mar 2026
Quantum Micro-Cardioplegia Delivery System
K240908 · Spectrum Medical , Ltd. · Jul 2025
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
K240190 · Medtronic · Feb 2024