510(k) · Cleared
ClearedQuantum Heater-Cooler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Ltd. · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on May 6, 2022 as substantially equivalent to K052601 (Sorin Group Deutschland GmbH, 2006) after a 256-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- May 6, 2022
- Review
- 256 days
- Class
- Class II
- Product code
- DWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883603 (1988). 5 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK883603 Sarns Temp. Control and Monitor System (TCM II)3M Health Care, Sarns · 1988 · Recalled
- 2 generations backK031544 Heater Cooler Unit, Model Hcu 30Jostra AB · 2003 · Recalled
- 1 generation backK052601 Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH · 2006 · Recalled
- This deviceK212657 Quantum Heater-CoolerSpectrum Medical, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883603 | Sarns Temp. Control and Monitor System (TCM II) | 3M Health Care, Sarns | 1988 | 4 |
| −2 | K031544 | Heater Cooler Unit, Model Hcu 30 | Jostra AB | 2003 | 4 |
| −1 | K052601 | Stockert Heater-Cooler System 3T | Sorin Group Deutschland GmbH | 2006 | 18 |
| 0 (this device) | K212657 | Quantum Heater-Cooler | Spectrum Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 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
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 |
|---|---|---|---|
| * | K052601 | Stockert Heater-Cooler System 3TSummary page 4…and Vascular Devices) III. PREDICATE DEVICE The predicate device for this submission is the Sorin/LivaNova Stöckert Heater-Cooler System 3T (K052601). IV. DEVICE DESCRIPTION The Quantum Heater-Cooler consists of the following components: • Quantum Heater-Cooler Unit (includ… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 14.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K052601.
How does its category compare?
All DWC devicesDWC Controller, Temperature, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Spectrum Medical Quantum Heater-Cooler is intended to provide temperature-controlled fluid to compatible Quantum PureFlow heat exchanger devices (cardiopulmonary bypass heat exchangers and cardioplegia heat exchangers) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.
The Quantum Heater-Cooler is only intended to be used by trained Clinicians in a clinical environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212657 · printed Nov 3, 2026
Cite this page
510(k) Report. “K212657: Quantum Heater-Cooler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K212657
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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