# 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

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: Dec 17, 2021 after 392 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K922933 (1992). 49 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 51 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150267: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators, Maquet Cardiopulmonary, AG (2015) Summary page 7.
- K150489: EOS PMP, EOS PMP Integrated, Sorin Group Italia S.R.L. (2015) Summary page 7.

## Most influential descendants
- K240934: Quantum 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); (2026), 0 descendants of its own

## Indications for use
Quantum Perfusion Blood Oxygenator ECC VT200-E2 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use. Devices are intended for adult patients. Quantum Perfusion Blood Oxygenator ECC VT200-E1 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Devices are intended for adult patients. Quantum Perfusion Blood Oxygenator ECC VT160-E2 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use. Devices are intended for adult patients. Quantum Perfusion Blood Oxygenator ECC VT160-E1 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Devices are intended for adult patients.

Source page: https://510kreport.com/device/K203424
Methodology: https://510kreport.com/methodology