510(k) · Cleared
ClearedConducer Heat Exchanger
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 Sep 18, 1992 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Sep 18, 1992
- Review
- 73 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK923311 Conducer Heat Exchanger3M Health Care, Sarns · 1992
- Descendant · cites it directly · 7 of its ownK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 5 of its ownK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- Descendant · 3 generations on · 4 of its ownK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 3 of its ownK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 2 of its ownK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K953838Myocardial Protection SystemQuest Medical, Inc. · 1996 · cites it directly7descendants
- K994274Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000 · 2 generations on5descendants
- K041979MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · 3 generations on4descendants
- K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · 4 generations on3descendants
- K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923311 | Conducer Heat Exchanger | 3M Health Care, Sarns | 1992 | — |
| +1 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| +2 | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc. | 2000 | — |
| +3 | K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260 | Quest Medical, Inc. | 2004 | 1 |
| +4 | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | 1 |
| +5 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 1 | 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 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? (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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K953838 (Quest Medical, Inc., 1996) has gone furthest, with 7 descendants of its own.
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/K923311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923311: Conducer Heat Exchanger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923311
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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