510(k) · Cleared
Recalled · 2005Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating
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 Mar 15, 2004 as substantially equivalent to K020106 (Gish Biomedical, Inc., 2002) after a 32-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Mar 15, 2004
- Review
- 32 days
- Class
- Class II
- Product code
- DTR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896807 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK896807 SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc. · 1990
- 1 generation backK020106 Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc. · 2002
- This deviceK040355 Vision Blood Cardioplegia System and Extracorporal Heat Exchanger…Gish Biomedical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896807 | SPBC Series Single Pass Blood Cardioplegia System | Gish Biomedical, Inc. | 1990 | — |
| −1 | K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger | Gish Biomedical, Inc. | 2002 | — |
| 0 (this device) | K040355 | Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS… | Gish Biomedical, Inc. | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerSummary page 1…ss heat exchanger 3. Predicate Devices: Gish Vision Blood Cardioplegia System and Extracorporal Heat Exchanger, Gish Biomedical, Inc., K020106. 4. Classifications Names & Citations: 21 CFR 870.4244), Cardiovascular bypass heat exchanger, Class II, DTR,… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2005 | Not classified | Z-0575-06 | Other | The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 11.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K020106.
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 System with GBS™ coating 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 or hypothermic applications. It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6.0) hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040355 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040355: Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040355
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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