Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

K-Number: K252541 · 2026-03-12

ApplicantSpectrum Medical S.R.L.
Decision Date2026-03-12
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is a medical device manufactured by Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2026-03-12 under approval number K252541. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Spectrum Medical S.R.L.. The 510(k) number is K252541.

When was Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W approved by the FDA?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W received FDA 510(k) clearance on 2026-03-12, under approval number K252541.

What company makes Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is manufactured by Spectrum Medical S.R.L..

What is the FDA product code for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

The FDA product code for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is DTR.

Related Clinical Trials

NCT07299006 Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children. RECRUITING NCT04670536 The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN) COMPLETED NCT05500885 The Clinical Effectiveness of Pulsed Electromagnetic Field Therapy on the Management of Chronic Ankle Instability COMPLETED

Other Devices by Spectrum Medical S.R.L.

K241206Quantum Perfusion Hybrid System K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

Related Devices (Code: DTR)

K162774MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)Medtronic, Inc. K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with BridgeMedtronic, Inc. K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑