# K231982: Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: Sep 12, 2024 after 435 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: 6 generations back to K915573 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090450: Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LT, Gish Biomedical, Inc. (2009) Summary page 6.

## Indications for use
Quantum Perfusion Blood Oxygenator 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. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to 1 m2. Quantum Perfusion Blood Oxygenator 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. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to 1 m2.

Source page: https://510kreport.com/device/K231982
Methodology: https://510kreport.com/methodology