510(k) · Cleared
Recalled · Class II · 2021Hemotherm Model 400CE Cooler/Heater System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cincinnati Sub-Zero Products, Inc. · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on Dec 18, 2012 as substantially equivalent to K811742 (Cincinnati Sub-Zero, 1981) and 2 other predicates after a 96-day review. Its family tree reaches back 4 generations to 2000. It has been recalled 6 times.
- Decided
- Dec 18, 2012
- Review
- 96 days
- Class
- Class II
- Product code
- DWC
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 4 generations to K003349 (2000). 10 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
- 3 generations backK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · Recalled
- 2 generations backK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
- 1 generation backK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010 · Recalled
- This deviceK122813 Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003349 | Allon 2001 Modified | Mtre Advanced Technology, Ltd. | 2000 | — |
| −3 | K024128 | Allon 2001 Version 5 | Mtre Advanced Technology, Ltd. | 2003 | 1 |
| −2 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 1 |
| −1 | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | Cincinnati Sub-Zero Products, Inc. | 2010 | 6 |
| 0 (this device) | K122813 | Hemotherm Model 400CE Cooler/Heater System | Cincinnati Sub-Zero Products, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K811742 | Hemotherm Model 400Summary page 1…DWJ when used with a hypo-hyperthermia blanket 9. PANEL: Cardiovascular 10. DEVICE CLASSIFICATION: Class 11 11. IDENTIFICATION OF PREDICATES: *K81 1742 Cincinnati Sub-Zero Hemnotherm Model 400 Cooler/Heater System *K03 1544 Jostra HCU 30 Heater-Cooler Dev… | 1981 |
| * | K031544 | Heater Cooler Unit, Model Hcu 30Summary page 1…IFICATION: Class 11 11. IDENTIFICATION OF PREDICATES: *K81 1742 Cincinnati Sub-Zero Hemnotherm Model 400 Cooler/Heater System *K03 1544 Jostra HCU 30 Heater-Cooler Device *K101589 Cincinnati Sub-Zero Blanketrol III Model 233 and blankets DEVICE DESCRIP… | 2003 |
| * | K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsSummary page 1…: *K81 1742 Cincinnati Sub-Zero Hemnotherm Model 400 Cooler/Heater System *K03 1544 Jostra HCU 30 Heater-Cooler Device *K101589 Cincinnati Sub-Zero Blanketrol III Model 233 and blankets DEVICE DESCRIPTION The Hemotherm® Model 400CE Cooler/Heater System is… | 2010 |
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 |
|---|---|---|---|---|
| Jun 17, 2021 | Class II | Z-2092-2021 | Process control | 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 water systems of any heater-cooler… |
| Dec 19, 2018 | Class II | Z-0825-2019 | Device Design | 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 host spot that led to discoloration… |
| Sep 4, 2018 | Class II | Z-0063-2019 | Device Design | 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 | Device Design | 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 & disinfection procedure. |
| Mar 9, 2017 | Class II | Z-1825-2017 | Component design/selection | Improperly rated fuses were used in the manufacture of the device. |
| Nov 7, 2016 | Class II | Z-0654-2017 | Material/Component Contamination | The device may not maintain water flow or temperature control. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K811742.
How does its category compare?
All DWC devicesDWC Controller, Temperature, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122813: Hemotherm Model 400CE Cooler/Heater System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122813
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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