510(k) · Cleared
ClearedSorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Cardiovascular, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Jul 2, 2002 as substantially equivalent to K934847 (Sorin Biomedical, Inc., 1994) after a 28-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 2, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934847 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK934847 Ngbcd & Ngbcdp Cardioplegia Delivery SystemsSorin Biomedical, Inc. · 1994 · Recalled
- This deviceK021830 Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia…Cobe Cardiovascular, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934847 | Ngbcd & Ngbcdp Cardioplegia Delivery Systems | Sorin Biomedical, Inc. | 1994 | 2 |
| 0 (this device) | K021830 | Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System | Cobe Cardiovascular, Inc. | 2002 | — |
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? (1)
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 |
|---|---|---|---|
| * | K934847 | Ngbcd & Ngbcdp Cardioplegia Delivery SystemsSummary page 2…emonstrate that the SMAR,T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847). Truthful and Accurate Statement A statement attesting to the truthfulness and accuracy of the information contained in this sub… | 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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K934847.
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 | — |
What is it indicated for?
The SMART BCD Vanguard Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021830: Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021830
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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