# K252541: Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical S.R.L.
- Decided: Mar 12, 2026 after 212 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: 9 generations back to K922933 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202206: AMG PMP Pediatric, Eurosets S.R.L (2021) Summary page 5.

## Indications for use
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W 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 with a maximum flow rate of 3.0 I/min. Device is intended for pediatric patients (BSA according following characteristics: 0.6 m2 < BSA <1 m2)

Source page: https://510kreport.com/device/K252541
Methodology: https://510kreport.com/methodology