510(k) · Cleared
ClearedSorin Blood Cardioplegia System
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 192-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 15, 1994
- Review
- 192 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK934763 Sorin Blood Cardioplegia SystemSorin Biomedical, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK020106 Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK250150 VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia…Sorin Group Italia S.R.L. · 2025
- Descendant · 2 generations on · 0 of its ownK081838 Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK040355 Vision Blood Cardioplegia System and Extracorporal Heat Exchanger…Gish Biomedical, Inc. · 2004 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K020106Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc. · 2002 · cites it directly2descendants
- K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…Sorin Group Italia S.R.L. · 2025 · cites it directly0descendants
- K081838Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc. · 2009 · 2 generations on0descendants
- K040355Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingGish Biomedical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934763 | Sorin Blood Cardioplegia System | Sorin Biomedical, Inc. | 1994 | — |
| +1 | K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger | Gish Biomedical, Inc. | 2002 | — |
| +1 | K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)… | Sorin Group Italia S.R.L. | 2025 | — |
| +2 | K081838 | Gish Vision Blood Cardioplegia with HA Coating | Gish Biomedical, Inc. | 2009 | — |
| +2 | K040355 | Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS… | Gish Biomedical, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 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 12.4 · 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? (4)
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, K020106 (Gish Biomedical, Inc., 2002) has gone furthest, with 2 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/K934763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934763: Sorin Blood Cardioplegia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934763
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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