Cleared Traditional

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

K252541 · Spectrum Medical S.R.L. · Cardiovascular
Mar 2026
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K252541 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 12, 2026, 212 days after receiving the submission on August 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K252541 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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