510(k) · Cleared
ClearedVision Blood Cardioplegia System and Extracorporeal Heat Exchanger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Apr 10, 2002 as substantially equivalent to K896807 (Gish Biomedical, Inc., 1990) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Apr 10, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896807 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK896807 SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc. · 1990
- This deviceK020106 Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK081838 Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK040355 Vision Blood Cardioplegia System and Extracorporal Heat Exchanger…Gish Biomedical, Inc. · 2004 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896807 | SPBC Series Single Pass Blood Cardioplegia System | Gish Biomedical, Inc. | 1990 | — |
| 0 (this device) | K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger | Gish Biomedical, Inc. | 2002 | — |
| +1 | K081838 | Gish Vision Blood Cardioplegia with HA Coating | Gish Biomedical, Inc. | 2009 | — |
| +1 | K040355 | Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS… | Gish Biomedical, Inc. | 2004 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K896807 | SPBC Series Single Pass Blood Cardioplegia SystemSummary page 1…mmon Name: Cardioplegia Heat Exchanger Clas§$ification Name; Cardiovascular bypass heat exchanger 3. Predicate Devices; Single pass Carduoplegla Gish Biomedical, Inc., K896807 & Vanguard and Dideco/Sorin K934763. 4. Classifications Names & Citations: 21 CFR 870%.4240, Cardiovascular bypass heat exchang… | 1990 |
| * | K934763 | Sorin Blood Cardioplegia SystemSummary page 1…er Clas§$ification Name; Cardiovascular bypass heat exchanger 3. Predicate Devices; Single pass Carduoplegla Gish Biomedical, Inc., K896807 & Vanguard and Dideco/Sorin K934763. 4. Classifications Names & Citations: 21 CFR 870%.4240, Cardiovascular bypass heat exchanger, Class I, DTR, Cardiovascular. 5… | 1994 |
What descends from it? (2)
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?
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 Vision Blood Cardioplegia is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic of hypothermic applications.
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/K020106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020106: Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020106
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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