# K031544: Heater Cooler Unit, Model Hcu 30

- Pathway: 510(k) (Traditional)
- Applicant: Jostra AB
- Decided: Aug 7, 2003 after 83 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883603 (1988). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883603: Sarns Temp. Control and Monitor System (TCM II), 3M Health Care, Sarns (1988) Summary page 1.

## Most influential descendants
- K052601: Stockert Heater-Cooler System 3T (2006), 4 descendants of its own
- K191402: Heater-Cooler System 3T (2020), 1 descendant of its own
- K220635: Heater-Cooler System 3T (2022), 0 descendants of its own
- K212657: Quantum Heater-Cooler (2022), 0 descendants of its own
- K140012: Sorin Flextherm (2014), 0 descendants of its own

## Recalls of this device
- Jul 14, 2021 · Class II · Z-2140-2021: There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
- Sep 27, 2016 · Class II · Z-0348-2017: There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
- Nov 13, 2015 · Class II · Z-0589-2016: Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Boar
- Nov 10, 2006 · Not classified · Z-0350-2007: The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool th

## Indications for use
The Jostra HCU 30 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/K031544
Methodology: https://510kreport.com/methodology