# K212688: Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: Jan 10, 2022 after 138 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- 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 K922933 (1992). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092895: Apex HP M Adult Hollow Fiber Membrane Oxygenator, Sorin Group Italia S.R.L. (2009) Summary page 5.
- K012898: Modification to: CSC14 Blood Cardioplegia System, Cobe Cardiovascular, Inc. (2001) Summary page 6.

## Most influential descendants
- K220110: Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (2022), 1 descendant of its own
- K223879: Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (2023), 0 descendants of its own

## Indications for use
The Quantum PureFlow Cardioplegia Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool cardioplegic solution, to remove air and to monitor the temperature during routine cardiopulmonary bypass (CPB) procedures up to 6 hours duration. Any blood to be treated must contain anticoagulant. Contact with cardioplegic solution for longer than this period is not permitted. Devices are intended for adult patients. 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) procedures up to 6 hours in duration. Devices are intended for adult patients.

Source page: https://510kreport.com/device/K212688
Methodology: https://510kreport.com/methodology