Cleared Special

K250150 - VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)

Also marketed or referenced as:
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt) VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

K250150 is an FDA 510(k) clearance for VANGUARD Blood cardioplegia Systems (Va..., manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Special 510(k) pathway after a 129-day FDA review.

K250150 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K250150

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.

DTR Device Classification - Class 2, Special Controls

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
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · Quara S.R.L. · Apr 2023
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
K220110 · Qura S.R.L · May 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
K212688 · Qura S.R.L · Jan 2022
K250150 · VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
Download PDF FDA Summary Sorin Group Italia S.…