510(k) · Cleared
Recalled · Class II · 2020Stockert Heater-Cooler System 3T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on Jun 6, 2006 as substantially equivalent to K811742 (Cincinnati Sub-Zero, 1981) and 2 other predicates after a 258-day review. Its family tree reaches back 2 generations to 1988. 4 later devices descend from it. It has been recalled 18 times.
- Decided
- Jun 6, 2006
- Review
- 258 days
- Class
- Class II
- Product code
- DWC
- Recalls
- 18
- Predicates
- 3
Its longest line of descent runs back 2 generations to K883603 (1988). 4 ancestors in all, the oldest K811742 (1981). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK883603 Sarns Temp. Control and Monitor System (TCM II)3M Health Care, Sarns · 1988 · Recalled
- 1 generation backK031544 Heater Cooler Unit, Model Hcu 30Jostra AB · 2003 · Recalled
- This deviceK052601 Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH · 2006
- Descendant · cites it directly · 1 of its ownK191402 Heater-Cooler System 3TLivanova Deutschland, GmbH · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK220635 Heater-Cooler System 3TLivanova Deutschland, GmbH · 2022
- Descendant · cites it directly · 0 of its ownK212657 Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK140012 Sorin FlexthermSorin Group Deutschland GmbH · 2014
Most influential descendants
Showing 4 of 4 · See all- K191402Heater-Cooler System 3TLivanova Deutschland, GmbH · 2020 · cites it directly1descendant
- K220635Heater-Cooler System 3TLivanova Deutschland, GmbH · 2022 · 2 generations on0descendants
- K212657Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022 · cites it directly0descendants
- K140012Sorin FlexthermSorin Group Deutschland GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883603 | Sarns Temp. Control and Monitor System (TCM II) | 3M Health Care, Sarns | 1988 | 4 |
| −1 | K031544 | Heater Cooler Unit, Model Hcu 30 | Jostra AB | 2003 | 4 |
| 0 (this device) | K052601 | Stockert Heater-Cooler System 3T | Sorin Group Deutschland GmbH | 2006 | — |
| +1 | K191402 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2020 | 1 |
| +2 | K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2022 | — |
| +1 | K212657 | Quantum Heater-Cooler | Spectrum Medical, Ltd. | 2022 | — |
| +1 | K140012 | Sorin Flextherm | Sorin Group Deutschland GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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…oler Classification Name: Cardiopulmonary bypass temperature controller 3. PREDICATE DEVICE * Cincinnati Subzero Hemotherm (CSZ Hemotherm) (K811742) • Alpha Omega, Inc. Dual 2 Cooler-Heater (K001520) * Jostra AB Heater-Cooler Unit 30 (K031544) 4.… | 1981 |
| * | K001520 | Alpha Omega Dual Cooler-HeaterSummary page 1…rature controller 3. PREDICATE DEVICE * Cincinnati Subzero Hemotherm (CSZ Hemotherm) (K811742) • Alpha Omega, Inc. Dual 2 Cooler-Heater (K001520) * Jostra AB Heater-Cooler Unit 30 (K031544) 4. DEVICE DESCRIPTION The Sorin Group Deutschland GmbH… | 2000 |
| * | K031544 | Heater Cooler Unit, Model Hcu 30Summary page 1…* Cincinnati Subzero Hemotherm (CSZ Hemotherm) (K811742) • Alpha Omega, Inc. Dual 2 Cooler-Heater (K001520) * Jostra AB Heater-Cooler Unit 30 (K031544) 4. DEVICE DESCRIPTION The Sorin Group Deutschland GmbH St6ckert Heater-Cooler System 3T consists of s… | 2003 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Feb 24, 2020 | Class II | Z-1498-2020 | Device Design | The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. |
| Nov 1, 2018 | Class II | Z-0220-2020 | Device Design | The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a… |
| Sep 14, 2018 | Class II | Z-1099-2019 | Material/Component Contamination | For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). |
| Apr 20, 2018 | Class II | Z-1901-2018 | Device Design | Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm. |
| Jun 30, 2017 | Class II | Z-2776-2017 | Device Design | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Jun 30, 2017 | Class II | Z-2775-2017 | Device Design | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Jun 30, 2017 | Class II | Z-2773-2017 | Device Design | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Jun 30, 2017 | Class II | Z-2772-2017 | Device Design | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Jun 30, 2017 | Class II | Z-2771-2017 | Device Design | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Jun 30, 2017 | Class II | Z-2774-2017 | Device Design | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Jun 15, 2015 | Class II | Z-2081-2015 | Error in labeling | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. |
| Jun 15, 2015 | Class II | Z-2079-2015 | Error in labeling | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. |
| Jun 15, 2015 | Class II | Z-2078-2015 | Error in labeling | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. |
| Jun 15, 2015 | Class II | Z-2080-2015 | Error in labeling | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. |
| Jun 15, 2015 | Class II | Z-2076-2015 | Error in labeling | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. |
| Jun 15, 2015 | Class II | Z-2077-2015 | Error in labeling | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. |
| Aug 1, 2014 | Class II | Z-0682-2017 | Material/Component Contamination | On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU). |
| Aug 15, 2012 | Class II | Z-1186-2016 | Device Design | On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water. |
The 5 latest of 18 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 18 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K191402 (Livanova Deutschland, GmbH, 2020) has gone furthest, with 1 descendant of its own.
- 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.
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 Stbckert Heater-Cooler System 3T is used with a St6ckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052601: Stockert Heater-Cooler System 3T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052601
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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