510(k) · Cleared
Recalled · Class II · 2023Cardioquip Modular Cooler-Heater Model MCH-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardioquip Llp · DWC Controller, Temperature, Cardiopulmonary Bypass
Cleared on Nov 19, 2010 after a 112-day review. The FDA summary names no predicate by number. It has been recalled 9 times.
- Decided
- Nov 19, 2010
- Review
- 112 days
- Class
- Class II
- Product code
- DWC
- Recalls
- 9
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|---|
| Oct 24, 2023 | Class II | Z-0565-2024 | Process control | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| Oct 24, 2023 | Class II | Z-0566-2024 | Process control | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| Oct 19, 2023 | Class II | Z-0438-2024 | Device Design | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| Oct 19, 2023 | Class II | Z-0439-2024 | Device Design | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| Jun 24, 2021 | Class II | Z-0069-2022 | Under Investigation by firm | There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery… |
| May 12, 2021 | Class II | Z-0036-2022 | Error in labeling | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| May 12, 2021 | Class II | Z-0035-2022 | Error in labeling | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| May 12, 2021 | Class II | Z-0037-2022 | Error in labeling | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| May 12, 2021 | Class II | Z-0038-2022 | Error in labeling | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DWC devicesDWC Controller, Temperature, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102147: Cardioquip Modular Cooler-Heater Model MCH-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102147
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026