510(k) · Cleared
ClearedBCD Advanced Blood Carioplegia Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Biomedica, Fiat, USA, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Mar 26, 1993 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Mar 26, 1993
- Review
- 154 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK925369 BCD Advanced Blood Carioplegia SystemsSorin Biomedica, Fiat, USA, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK960755 Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK991137 Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000
- Descendant · 2 generations on · 0 of its ownK973237 CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK973475 Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx…Medtronic Vascular · 1997
- Descendant · cites it directly · 0 of its ownK964571 Vision Cardioplegia Delivery SystemLifestream Int'L, Inc. · 1997
Most influential descendants
Showing 5 of 5 · See all- K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996 · cites it directly3descendants
- K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000 · cites it directly0descendants
- K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998 · 2 generations on0descendants
- K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr…Medtronic Vascular · 1997 · 2 generations on0descendants
- K964571Vision Cardioplegia Delivery SystemLifestream Int'L, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925369 | BCD Advanced Blood Carioplegia Systems | Sorin Biomedica, Fiat, USA, Inc. | 1993 | — |
| +1 | K960755 | Cardiotherm Blood Cardioplegia Systems | Medtronic Cardiac Surgery, Medtronic, Inc. | 1996 | — |
| +1 | K991137 | Enguard PHX Cardioplegia Heat Exchanger | Minntech Corp. | 2000 | — |
| +2 | K973237 | CSS-Cardioplegia Safety System | Medtronic Bio-Medicus, Inc. | 1998 | — |
| +2 | K973475 | Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and… | Medtronic Vascular | 1997 | — |
| +1 | K964571 | Vision Cardioplegia Delivery System | Lifestream Int'L, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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? (5)
3 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, K960755 (Medtronic Cardiac Surgery, Medtronic, Inc., 1996) has gone furthest, with 3 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/K925369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925369: BCD Advanced Blood Carioplegia Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925369
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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