510(k) · Cleared
ClearedCbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Dec 21, 2000 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.
- Decided
- Dec 21, 2000
- Review
- 17 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 3 citing it directly.
- This deviceK003724 Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive…Medtronic Vascular · 2000
- Descendant · cites it directly · 27 of its ownK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- Descendant · 2 generations on · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
- Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- Descendant · 3 generations on · 8 of its ownK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
- Descendant · 4 generations on · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002 · cites it directly27descendants
- K022366Celsius Control SystemInnercool Therapies · 2003 · 2 generations on16descendants
- K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
- K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005 · 3 generations on8descendants
- K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003724 | Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface… | Medtronic Vascular | 2000 | — |
| +1 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| +2 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| +2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| +3 | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | — |
| +4 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (36)
See all 363 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, K012512 (Radiant Medical, 2002) has gone furthest, with 27 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/K003724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003724: Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003724
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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