Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W— 510(k) K252541
Substantially EquivalentSpectrum Medical S.R.L.
FDA 510(k) clearance K252541 for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W, Substantially Equivalent on 2026-03-12. Applicant: Spectrum Medical S.R.L.. Device class: 2.
Summary
Spectrum Medical's Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is filed under DTR, cardiopulmonary bypass heat exchangers. The record doesn't describe it beyond that name and code name.
Class II, 21 CFR 870.4240. It was a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.
Spectrum Medical filed from Mirandola, Italy. The decision came 212 calendar days after FDA received it (August 12, 2025 to March 12, 2026).
Clearance details
- Applicant
- Spectrum Medical S.R.L.
- Product code
- Product code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
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- K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
More clearances from Spectrum Medical S.R.L.
view all- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more
- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K241206 — Quantum Perfusion Hybrid System
- K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
Adverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.