# K223879: Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)

- Pathway: 510(k) (Special)
- Applicant: Quara S.R.L.
- Decided: Apr 13, 2023 after 107 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K922933 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220110: Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger, Qura S.R.L (2022) Summary page 4.

## Recalls of this device
- Jul 17, 2026 · Class II · Z-3327-2026: Due to blood-to-glycol leak in the heat exchanger.
- Jul 17, 2026 · Class II · Z-3328-2026: Due to blood-to-glycol leak in the heat exchanger.

## Indications for use
The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedure up to 6 hours in duration. Devices are intended for adult patients.

Source page: https://510kreport.com/device/K223879
Methodology: https://510kreport.com/methodology