510(k) · Cleared
Recalled · 2010MPS Myocardial Protection System - MPS 2 Console, Model 5201260
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 Sep 2, 2004 as substantially equivalent to K994274 (Quest Medical, Inc., 2000) after a 41-day review. Its family tree reaches back 3 generations to 1980. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- DTR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K802147 (1980). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK802147 Shiley Temperature MonitorShiley, Inc. · 1980
- 2 generations backK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- 1 generation backK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- This deviceK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK201984 MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK240908 Quantum Micro-Cardioplegia Delivery System; Quantum…Spectrum Medical, Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · cites it directly3descendants
- K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020 · 2 generations on2descendants
- K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020 · 3 generations on1descendant
- K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…Spectrum Medical, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| −2 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| −1 | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc. | 2000 | — |
| 0 (this device) | K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260 | Quest Medical, Inc. | 2004 | — |
| +1 | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | 1 |
| +2 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +3 | K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +4 | K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia… | Spectrum Medical, Ltd. | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Summary page 1…Myocardial Perfusion System Classification: Class II, 21 CFR 870.4240 3. PREDICATE DEVICE: MPS Myocardial Protection System: K994274 4. DEVICE DESCRIPTION: The MPS 2 console is a single device for myocardial perfusion that incorporates several differen… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173716 | MPS2 Myocardial Protection System Console | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2010 | Not classified | Z-1924-2011 | Other | User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K173716 (Quest Medical, Inc., 2018) 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 | — |
What is it indicated for?
The Quest Medical MPS® 2 Myocardial Protection System, consisting of the MPS 2 Console and the MPS Delivery Set together, is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and / or cardioplegia solutions to the head during open heart surgery on either an arrested or beating heart for use up to six hours in duration
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041979: MPS Myocardial Protection System - MPS 2 Console, Model 5201260.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041979
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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