510(k) · Cleared
Recalled · Class II · 2021Sarns Temp. Control and Monitor System (TCM II)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on Nov 3, 1988 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 3, 1988
- Review
- 72 days
- Class
- Class II
- Product code
- DWC
- Recalls
- 4
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK883603 Sarns Temp. Control and Monitor System (TCM II)3M Health Care, Sarns · 1988
- Descendant · cites it directly · 7 of its ownK031544 Heater Cooler Unit, Model Hcu 30Jostra AB · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK052601 Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH · 2006 · Recalled
- Descendant · 3 generations on · 1 of its ownK191402 Heater-Cooler System 3TLivanova Deutschland, GmbH · 2020 · Recalled
- Descendant · 4 generations on · 0 of its ownK220635 Heater-Cooler System 3TLivanova Deutschland, GmbH · 2022
- Descendant · 3 generations on · 0 of its ownK212657 Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K031544Heater Cooler Unit, Model Hcu 30Jostra AB · 2003 · cites it directly7descendants
- K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH · 2006 · 2 generations on4descendants
- K191402Heater-Cooler System 3TLivanova Deutschland, GmbH · 2020 · 3 generations on1descendant
- K220635Heater-Cooler System 3TLivanova Deutschland, GmbH · 2022 · 4 generations on0descendants
- K212657Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883603 | Sarns Temp. Control and Monitor System (TCM II) | 3M Health Care, Sarns | 1988 | — |
| +1 | K031544 | Heater Cooler Unit, Model Hcu 30 | Jostra AB | 2003 | 4 |
| +2 | K052601 | Stockert Heater-Cooler System 3T | Sorin Group Deutschland GmbH | 2006 | 18 |
| +3 | K191402 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2020 | 1 |
| +4 | K220635 | Heater-Cooler System 3T | Livanova Deutschland, GmbH | 2022 | — |
| +3 | K212657 | Quantum Heater-Cooler | Spectrum Medical, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 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 |
|---|---|---|---|---|
| Apr 16, 2021 | Class II | Z-1791-2021 | 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-1418-2018 | Labeling design | Update to cooler-heater cleaning instructions. |
| Jun 8, 2016 | Class II | Z-2209-2016 | 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… |
| May 30, 2013 | Class II | Z-1569-2013 | Employee error | Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031544 (Jostra AB, 2003) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K883603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K883603: Sarns Temp. Control and Monitor System (TCM II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883603
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026