Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
FDA 510(k) K252541 · Spectrum Medical S.R.L.
510(k) numberK252541
Submission
- Device name
- Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
- Applicant
- Spectrum Medical S.R.L.
Mirandola, IT - Received
- August 12, 2025
- Decision date
- March 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4240
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | Spectrum Medical , Ltd. | 07/08/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special | Medtronic | 02/23/2024SE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 05/06/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 01/10/2022SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 06/19/2020SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Traditional | Medtronic, Inc. | 02/10/2017SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | 03/12/2026SE |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional | 08/04/2025SE |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM · Traditional | 06/24/2025SE |
| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | 07/18/2024SE |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)DWF · Special | 05/31/2024SE |
Questions and answers
When was Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W cleared by the FDA?
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (K252541) received a 510(k) decision of Substantially Equivalent on March 12, 2026, 212 days after the submission was received.
What is the product code of K252541?
The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.