510(k) · Cleared
ClearedVision Cardioplegia Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifestream Int'L, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Aug 8, 1997 as substantially equivalent to K925369 (Sorin Biomedica, Fiat, USA, Inc., 1993) and 1 other predicate after a 267-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 8, 1997
- Review
- 267 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904171 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904171 Scimed Cardiotherm Cardioplegia Delivery SystemScimed · 1990
- This deviceK964571 Vision Cardioplegia Delivery SystemLifestream Int'L, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904171 | Scimed Cardiotherm Cardioplegia Delivery System | Scimed | 1990 | — |
| 0 (this device) | K964571 | Vision Cardioplegia Delivery System | Lifestream Int'L, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (3)
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 |
|---|---|---|---|
| * | K925369 | BCD Advanced Blood Carioplegia SystemsSummary page 1…legally marketed cardioplegia heat exchangers: Sorin Biomedical Buckberg BCD Vanguard (No K number identified) Sorin Biomedical BCD Advanced Blood Cardioplegia System (K925369) Avecor Cardiovascular MYOtherm Cardioplegia System (K904171) SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System - 510(k) Sum… | 1993 |
| * | K904171 | Scimed Cardiotherm Cardioplegia Delivery SystemSummary page 1…ical Buckberg BCD Vanguard (No K number identified) Sorin Biomedical BCD Advanced Blood Cardioplegia System (K925369) Avecor Cardiovascular MYOtherm Cardioplegia System (K904171) SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System - 510(k) Summary 11/13/96 Page 1 7. Device Description an… | 1990 |
| * | — | Sorin Biomedical Buckberg BCD Vanguard Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K925369.
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 SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix,
cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary
bypass.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964571: Vision Cardioplegia Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964571
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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