510(k) · Cleared
Recalled · Class II · 2021Terumo HX2 Temperature Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on Nov 21, 2007 as substantially equivalent to K883603 (3M Health Care, Sarns, 1988) after a 170-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 7 times.
- Decided
- Nov 21, 2007
- Review
- 170 days
- Class
- Class II
- Product code
- DWC
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883603 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK883603 Sarns Temp. Control and Monitor System (TCM II)3M Health Care, Sarns · 1988 · Recalled
- This deviceK071521 Terumo HX2 Temperature Management SystemTerumo Cardiovascular Systems Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883603 | Sarns Temp. Control and Monitor System (TCM II) | 3M Health Care, Sarns | 1988 | 4 |
| 0 (this device) | K071521 | Terumo HX2 Temperature Management System | Terumo Cardiovascular Systems Corp. | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWC device
- #1 K220635 Heater-Cooler System 3Tscore 5.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883603 | Sarns Temp. Control and Monitor System (TCM II)Summary page 1…troller (21 CFR 870.4250) Legally Marketed Predicate Device: T Sarns M Dual Cooler/Heater (Preamendment) Sarns TM Temperature Control and Monitor System (TCM II)(K883603) Indications for Use: The Terumo® HX2TM Temperature Management System is indicated for use to supply temperature regulated water… | 1988 |
| * | — | Sarns TM Dual Cooler/Heater (Preamendment) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2021 | Class II | Z-1789-2021 | Device Design | 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 has been determined that the best… |
| Mar 16, 2018 | Class II | Z-1416-2018 | Labeling design | Update to cooler-heater cleaning instructions. |
| Jun 8, 2016 | Class II | Z-2207-2016 | Nonconforming Material/Component | 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 in its heater-cooler cleaning… |
| Feb 6, 2015 | Class II | Z-1116-2015 | Device Design | 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 move or complete a motion). Mixing… |
| Oct 16, 2012 | Class II | Z-0278-2013 | Nonconforming Material/Component | 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 material. Use of the incorrect flux may… |
| Oct 16, 2012 | Class II | Z-0279-2013 | Nonconforming Material/Component | 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 material. Use of the incorrect flux may… |
| Jun 11, 2010 | Not classified | Z-2060-2010 | Device Design | The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K883603.
How does its category compare?
All DWC devicesDWC Controller, Temperature, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DWC
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DWC
Too few DWC 510(k)s in any year since 2007 to give a median.
Recalls per year · DWC
5in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWC
670in 2025
MAUDE reports naming product code DWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 1 | 243 |
| 2011 | 0 | — | 0 | 281 |
| 2012 | 1 | — | 2 | 351 |
| 2013 | 1 | — | 0 | 244 |
| 2014 | 1 | — | 1 | 378 |
| 2015 | 0 | — | 1 | 575 |
| 2016 | 0 | — | 1 | 787 |
| 2017 | 0 | — | 1 | 716 |
| 2018 | 0 | — | 3 | 564 |
| 2019 | 0 | — | 0 | 697 |
| 2020 | 1 | — | 0 | 548 |
| 2021 | 0 | — | 5 | 622 |
| 2022 | 2 | — | 0 | 605 |
| 2023 | 0 | — | 5 | 928 |
| 2024 | 0 | — | 0 | 555 |
| 2025 | 0 | — | 0 | 670 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071521: Terumo HX2 Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071521
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026