# 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);

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical S.R.L.
- Decided: Mar 12, 2026 after 706 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: 12 generations back to K922933 (1992). 50 ancestors in all.
No later device cites it as a predicate yet.
1 of 51 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Qura S.R.L (2021) Summary page 6.

## Indications for use
Quantum Perfusion Blood Oxygenator VT75-E3 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 Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to 1 m2. Quantum Perfusion Blood Oxygenator VT160- E3 and VT200-E3 are 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 devices are limited to 6 hours of use. Devices are intended for adult patients.

Source page: https://510kreport.com/device/K240934
Methodology: https://510kreport.com/methodology