# K122813: Hemotherm Model 400CE Cooler/Heater System

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Dec 18, 2012 after 96 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003349 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811742: Hemotherm Model 400, Cincinnati Sub-Zero (1981) Summary page 1.
- K031544: Heater Cooler Unit, Model Hcu 30, Jostra AB (2003) Summary page 1.
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems, Cincinnati Sub-Zero Products, Inc. (2010) Summary page 1.

## Recalls of this device
- Jun 17, 2021 · Class II · Z-2092-2021: There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the wat
- Dec 19, 2018 · Class II · Z-0825-2019: Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a
- Sep 4, 2018 · Class II · Z-0063-2019: Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
- Nov 27, 2017 · Class II · Z-0629-2018: Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfect
- Mar 9, 2017 · Class II · Z-1825-2017: Improperly rated fuses were used in the manufacture of the device.
- Nov 7, 2016 · Class II · Z-0654-2017: The device may not maintain water flow or temperature control.

## Indications for use
The Hemotherm® Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

Source page: https://510kreport.com/device/K122813
Methodology: https://510kreport.com/methodology