# Qura S.R.L

- Location (FDA's records): Mirandola, IT
- FDA decisions: 15 (2020–2024): 15 510(k) clearances
- Product codes: KFM (5), DTZ (4), DWF (4), DTR (2)
- 510(k) review time since 2016: median 329 days, against 135 for FDA's reviews in the same codes and years (1 of 10 faster)
- Predicates its devices cite: 18 (5 its own); citations of its devices by later devices: 10 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sorin Group Italia S.R.L.: 4 (https://510kreport.com/company/sorin-group-italia)
- Cobe Cardiovascular, Inc.: 2 (https://510kreport.com/company/cobe-cardiovascular)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)
- Levitronix, LLC: 1 (https://510kreport.com/company/levitronix)
- Cardiacassist, Inc.: 1 (https://510kreport.com/company/cardiacassist)
- Gish Biomedical, Inc.: 1 (https://510kreport.com/company/gish-biomedical)
- Vascutek, Ltd.: 1 (https://510kreport.com/company/vascutek)

## Firms that cite its devices most
- Spectrum Medical, Ltd.: 4 (https://510kreport.com/company/spectrum-medical)
- Quara S.R.L.: 1 (https://510kreport.com/company/quara)

## Its most-cited devices
- K201320: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (2021), cited by 2
- K212688: Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (2022), cited by 1
- K203424: Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1,  Quantum Perfusion Blood Oxygenator ECC VT160-E2 (2021), cited by 1
- K220842: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (2023), cited by 1
- K221353: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (2022), cited by 1
- K203067: Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (2021), cited by 1

## Recent decisions
- K231982: Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 (Sep 12, 2024)
- K231773: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U (Nov 8, 2023)
- K233091: Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) (Oct 26, 2023)
- K220842: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (May 19, 2023)
- K221353: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (Aug 18, 2022)
- K213540: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set (May 20, 2022)
- K220110: Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (May 6, 2022)
- K212341: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U (Jan 28, 2022)

Source page: https://510kreport.com/company/qura