510(k) · Cleared
Recalled · Class II · 2015Myocardial Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Mar 6, 1996 as substantially equivalent to K810079 (3M Health Care, Sarns, 1981) and 5 other predicates after a 203-day review. Its family tree reaches back 1 generation to 1980. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 6, 1996
- Review
- 203 days
- Class
- Class II
- Product code
- DTR
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 1 generation to K802147 (1980). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK802147 Shiley Temperature MonitorShiley, Inc. · 1980
- This deviceK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996
- Descendant · cites it directly · 5 of its ownK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- Descendant · 2 generations on · 4 of its ownK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 3 of its ownK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 2 of its ownK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 5 generations on · 1 of its ownK201984 MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K994274Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000 · cites it directly5descendants
- K041979MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · 2 generations on4descendants
- K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · 3 generations on3descendants
- K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020 · 4 generations on2descendants
- K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| 0 (this device) | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | — |
| +1 | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc. | 2000 | — |
| +2 | K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260 | Quest Medical, Inc. | 2004 | 1 |
| +3 | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | 1 |
| +4 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +5 | K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (6)
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 |
|---|---|---|---|
| * | K810079 | Sarns Integrated Cardioplegia Deliv. SysSummary page 2…afety and Effectiveness Substantial Equivalence: The device has been shown to be substantially equivalent to the Sarns’ Integrated Cardioplegia Delivery System (ICDS) #K810079, Sams Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K86… | 1981 |
| * | K923311 | Conducer Heat ExchangerSummary page 2…ivalence: The device has been shown to be substantially equivalent to the Sarns’ Integrated Cardioplegia Delivery System (ICDS) #K810079, Sams Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 80214… | 1992 |
| * | K904171 | Scimed Cardiotherm Cardioplegia Delivery SystemSummary page 2…own to be substantially equivalent to the Sarns’ Integrated Cardioplegia Delivery System (ICDS) #K810079, Sams Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 802147and the Stockert-Shiley Dual Pre… | 1990 |
| * | K864619 | Caps Low Level Detector & Detector/Bubble MonitorSummary page 2…ardioplegia Delivery System (ICDS) #K810079, Sams Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 802147and the Stockert-Shiley Dual Pressure Control Module # K862836. VL. Other Safety and Effecti… | 1987 |
| * | K802147 | Shiley Temperature MonitorSummary page 2…10079, Sams Conducer Heat Exchanger # K923311, Avecor Heat Exchanger # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 802147and the Stockert-Shiley Dual Pressure Control Module # K862836. VL. Other Safety and Effectiveness Data: Materials: Fluid contac… | 1980 |
| * | K862836 | Stockert-Shiley Caps and Caps Dual Pressure ModuleSummary page 2…changer # K904171, Stockert-Shiley Low Level Detector Bubble Monitor # K864619, Shiley Temperature Monitor # 802147and the Stockert-Shiley Dual Pressure Control Module # K862836. VL. Other Safety and Effectiveness Data: Materials: Fluid contact materials of construction comply with ISO-10993 “ Biological… | 1986 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2015 | Class II | Z-0361-2016 | Equipment maintenance | The products have been found to intermittently exhibit a seal failure during use. |
| Jul 29, 2010 | Not classified | Z-1924-2011 | Other | User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. |
| May 23, 2003 | Not classified | Z-1037-03 | Other | Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K994274 (Quest Medical, Inc., 2000) has gone furthest, with 5 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 | — |
What is it indicated for?
The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery
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/K953838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953838: Myocardial Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953838
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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