# K130300: Heater-Cooler Unit Hcu 40

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Jul 1, 2013 after 144 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883603 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031544: Heater Cooler Unit, Model Hcu 30, Jostra AB (2003) Summary page 1.

## Indications for use
The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

Source page: https://510kreport.com/device/K130300
Methodology: https://510kreport.com/methodology