510(k) · Cleared
ClearedSPBC Series Single Pass Blood Cardioplegia System
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 Jul 31, 1990 after a 239-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jul 31, 1990
- Review
- 239 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK896807 SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK960755 Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK020106 Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK081838 Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK040355 Vision Blood Cardioplegia System and Extracorporal Heat Exchanger…Gish Biomedical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK991137 Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996 · cites it directly3descendants
- K020106Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc. · 2002 · cites it directly2descendants
- K081838Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc. · 2009 · 2 generations on0descendants
- K040355Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingGish Biomedical, Inc. · 2004 · 2 generations on0descendants
- K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896807 | SPBC Series Single Pass Blood Cardioplegia System | Gish Biomedical, Inc. | 1990 | — |
| +1 | K960755 | Cardiotherm Blood Cardioplegia Systems | Medtronic Cardiac Surgery, Medtronic, Inc. | 1996 | — |
| +1 | K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger | Gish Biomedical, Inc. | 2002 | — |
| +2 | K081838 | Gish Vision Blood Cardioplegia with HA Coating | Gish Biomedical, Inc. | 2009 | — |
| +2 | K040355 | Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS… | Gish Biomedical, Inc. | 2004 | 1 |
| +2 | K991137 | Enguard PHX Cardioplegia Heat Exchanger | Minntech Corp. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K960755 (Medtronic Cardiac Surgery, Medtronic, Inc., 1996) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K896807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K896807: SPBC Series Single Pass Blood Cardioplegia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896807
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026