510(k) · Cleared
Recalled · Class II · 2011Clear Cardioplejia Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Jan 14, 1983 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 14 times.
- Decided
- Jan 14, 1983
- Review
- 58 days
- Class
- Class II
- Product code
- DTR
- Recalls
- 14
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 DTR? 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 DTR device
- #1 K252541 Quantum PureFlow Standard Heat Exchanger…score 13.4 · 9 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?
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 |
|---|---|---|---|---|
| Mar 1, 2011 | Class II | Z-0158-2015 | Device Design | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line |
| Jun 8, 2010 | Not classified | Z-2161-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2157-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2162-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2154-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2159-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2158-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2155-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2153-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2151-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2152-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2156-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2149-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
| Jun 8, 2010 | Not classified | Z-2160-2010 | Equipment maintenance | Vent port may be occluded and prevent delivery of fluid |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTR
Too few DTR 510(k)s in any year since 2007 to give a median.
Recalls per year · DTR
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTR
44in 2025
MAUDE reports naming product code DTR, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 24 | 43 |
| 2011 | 0 | — | 3 | 67 |
| 2012 | 0 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 0 | — | 1 | 96 |
| 2016 | 0 | — | 0 | 60 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 75 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 2 | — | 0 | 23 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 2 | — | 0 | 44 |
| 2026 | 1 | — | 2 | — |
https://510kreport.com/device/K823451 · printed Nov 4, 2026
Cite this page
510(k) Report. “K823451: Clear Cardioplejia Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K823451
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026