510(k) · Cleared
ClearedVANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on May 30, 2025 as substantially equivalent to K934763 (Sorin Biomedical, Inc., 1994) and 1 other predicate after a 129-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 30, 2025
- Review
- 129 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934763 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK934763 Sorin Blood Cardioplegia SystemSorin Biomedical, Inc. · 1994
- This deviceK250150 VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia…Sorin Group Italia S.R.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934763 | Sorin Blood Cardioplegia System | Sorin Biomedical, Inc. | 1994 | — |
| 0 (this device) | K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)… | Sorin Group Italia S.R.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934763 | Sorin Blood Cardioplegia SystemSummary page 6…fied and unmodified models have the same fundamental scientific technology and intended use: 510(k) Number: K934763 Device Trade Name: SORIN BLOOD CARDIOPLEGIA… | 1994 |
| * | K934847 | Ngbcd & Ngbcdp Cardioplegia Delivery SystemsSummary page 6…: Class II Classification Panel: Cardiovascular 510(k) Number: K934847 Device Trade Name: NGBCD & NGBCDP… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K934763.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250150 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250150: VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250150
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026