# K071521: Terumo HX2 Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Nov 21, 2007 after 170 days
- Product code: DWC (Controller, Temperature, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4250
- Recalls of this device: 7 (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.
No later device cites it as a predicate yet.
0 of 2 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.
- (no number) Sarns TM Dual Cooler/Heater (Preamendment): named in the summary without a submission number

## Recalls of this device
- Apr 16, 2021 · Class II · Z-1789-2021: Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it
- Mar 16, 2018 · Class II · Z-1416-2018: Update to cooler-heater cleaning instructions.
- Jun 8, 2016 · Class II · Z-2207-2016: Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced
- Feb 6, 2015 · Class II · Z-1116-2015: Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to
- Oct 16, 2012 · Class II · Z-0278-2013: Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux mater
- Oct 16, 2012 · Class II · Z-0279-2013: Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux mater
- Jun 11, 2010 · Not classified · Z-2060-2010: The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode.

## Indications for use
The Terumo® HX2TM Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery. Operation 100 to 400 C, less than 75% relative humidity, non-condensing. Storage Ventilated area, -300 to 54 0C (-22 to 130 0F), less than 95% relative humidity, non-condensing. Transporting Units may be transported up or down an incline of up to 15 degrees without tipping.

Source page: https://510kreport.com/device/K071521
Methodology: https://510kreport.com/methodology