510(k) · Cleared
Recalled · 2004Ngbcd & Ngbcdp Cardioplegia Delivery Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Biomedical, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Apr 15, 1994 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 15, 1994
- Review
- 189 days
- Class
- Class II
- Product code
- DTN
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK934847 Ngbcd & Ngbcdp Cardioplegia Delivery SystemsSorin Biomedical, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK012898 Modification to: CSC14 Blood Cardioplegia SystemCobe Cardiovascular, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK212688 Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow…Qura S.R.L · 2022
- Descendant · 2 generations on · 2 of its ownK072583 Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2008
- Descendant · 3 generations on · 1 of its ownK220110 Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow…Qura S.R.L · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK090555 Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012898Modification to: CSC14 Blood Cardioplegia SystemCobe Cardiovascular, Inc. · 2001 · cites it directly6descendants
- K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · 2 generations on2descendants
- K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG · 2008 · 2 generations on2descendants
- K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L · 2022 · 3 generations on1descendant
- K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG · 2009 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934847 | Ngbcd & Ngbcdp Cardioplegia Delivery Systems | Sorin Biomedical, Inc. | 1994 | — |
| +1 | K012898 | Modification to: CSC14 Blood Cardioplegia System | Cobe Cardiovascular, Inc. | 2001 | — |
| +2 | K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat… | Qura S.R.L | 2022 | — |
| +2 | K072583 | Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30… | Maquet Cardiopulmonary, AG | 2008 | — |
| +3 | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia… | Qura S.R.L | 2022 | 2 |
| +3 | K090555 | Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 | Maquet Cardiopulmonary, AG | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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 DTN? 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.3 · 7 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012898 | Modification to: CSC14 Blood Cardioplegia System | 2001 | 6 |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD… | 2025 | 0 |
| K021830 | Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System | 2002 | 0 |
| K982467 | Capiox Cardioplegia | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2004 | Not classified | Z-1009-04 | Other | Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia. |
| May 9, 2003 | Not classified | Z-0960-03 | Other | Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012898 (Cobe Cardiovascular, Inc., 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K934847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934847
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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