510(k) · Cleared
Recalled · Class II · 2011Sarns Integrated Cardioplegia Deliv. Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · KRI Accessory Equipment, Cardiopulmonary Bypass
Cleared on Jan 30, 1981 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 30, 1981
- Review
- 17 days
- Class
- Class I
- Product code
- KRI
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK810079 Sarns Integrated Cardioplegia Deliv. Sys3M Health Care, Sarns · 1981
- Descendant · cites it directly · 7 of its ownK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 5 of its ownK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- Descendant · 3 generations on · 4 of its ownK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 3 of its ownK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 2 of its ownK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K953838Myocardial Protection SystemQuest Medical, Inc. · 1996 · cites it directly7descendants
- K994274Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000 · 2 generations on5descendants
- K041979MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · 3 generations on4descendants
- K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · 4 generations on3descendants
- K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810079 | Sarns Integrated Cardioplegia Deliv. Sys | 3M Health Care, Sarns | 1981 | — |
| +1 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| +2 | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc. | 2000 | — |
| +3 | K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260 | Quest Medical, Inc. | 2004 | 1 |
| +4 | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | 1 |
| +5 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 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 KRI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K953838 | Myocardial Protection System | 1996 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2011 | Class II | Z-0157-2015 | Device Design | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K953838 (Quest Medical, Inc., 1996) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KRI devicesKRI Accessory Equipment, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRI
FDA has decided no KRI device since 2007.
Median 510(k) review, days · KRI
Too few KRI 510(k)s in any year since 2007 to give a median.
Recalls per year · KRI
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRI
5in 2023
MAUDE reports naming product code KRI, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K810079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K810079: Sarns Integrated Cardioplegia Deliv. Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K810079
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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