Cleared Traditional

K252541 - Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

K252541 is an FDA 510(k) clearance for Quantum PureFlow Standard Heat Exchange..., manufactured by Spectrum Medical S.R.L.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K252541 · Spectrum Medical S.R.L. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
212d
Days
Class 2
Risk

K252541 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 12, 2026 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 Spectrum Medical S.R.L. devices

FDA 510(k) Submission Details - K252541

510(k) Number K252541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2025
Decision Date March 12, 2026
Days to Decision 212 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 slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 84
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K252541.
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K240190 · Medtronic · Feb 2024
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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