510(k) · Cleared
Recalled · Class II · 2021Heater Cooler Unit, Model Hcu 30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jostra AB · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on Aug 7, 2003 as substantially equivalent to K883603 (3M Health Care, Sarns, 1988) after an 83-day review. Its family tree reaches back 1 generation to 1988. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 7, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- DWC
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883603 (1988). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK883603 Sarns Temp. Control and Monitor System (TCM II)3M Health Care, Sarns · 1988 · Recalled
- This deviceK031544 Heater Cooler Unit, Model Hcu 30Jostra AB · 2003
- Descendant · cites it directly · 4 of its ownK052601 Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK191402 Heater-Cooler System 3TLivanova Deutschland, GmbH · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK220635 Heater-Cooler System 3TLivanova Deutschland, GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK212657 Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK140012 Sorin FlexthermSorin Group Deutschland GmbH · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH · 2006 · cites it directly4descendants
- K191402Heater-Cooler System 3TLivanova Deutschland, GmbH · 2020 · 2 generations on1descendant
- K220635Heater-Cooler System 3TLivanova Deutschland, GmbH · 2022 · 3 generations on0descendants
- K212657Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022 · 2 generations on0descendants
- K140012Sorin FlexthermSorin Group Deutschland GmbH · 2014 · 2 generations on0descendants
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) | K031544 | Heater Cooler Unit, Model Hcu 30 | Jostra AB | 2003 | — |
| +1 | K052601 | Stockert Heater-Cooler System 3T | Sorin Group Deutschland GmbH | 2006 | 18 |
| +2 | K191402 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2020 | 1 |
| +3 | K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2022 | — |
| +2 | K212657 | Quantum Heater-Cooler | Spectrum Medical, Ltd. | 2022 | — |
| +2 | K140012 | Sorin Flextherm | Sorin Group Deutschland GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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? (1)
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…mes: Controller, Temperature, Cardiopulmonary Bypass Predicate Device: Sarns temperature control and monitor system (TCM 11) K883603 Device Description: The Jostra Heater-Cooler Unit HCU 30 supplies temperature-controlled water for cardioplegia heat exchanger… | 1988 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2021 | Class II | Z-2140-2021 | Device Design | 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 | Device Design | 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 | Device Design | 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. Board failure typically occurs when the… |
| Nov 10, 2006 | Not classified | Z-0350-2007 | Other | 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 the patient and/or cardioplegia… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DWC devicesDWC Controller, Temperature, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031544: Heater Cooler Unit, Model Hcu 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031544
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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