510(k) · Cleared
Recalled · Class II · 2019MPS2 Myocardial Protection System Console
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 Oct 1, 2018 as substantially equivalent to K041979 (Quest Medical, Inc., 2004) after a 300-day review. Its family tree reaches back 4 generations to 1980. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2018
- Review
- 300 days
- Class
- Class II
- Product code
- DTR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K802147 (1980). 9 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK802147 Shiley Temperature MonitorShiley, Inc. · 1980
- 3 generations backK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- 2 generations backK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- 1 generation backK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- This deviceK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK201984 MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK240908 Quantum Micro-Cardioplegia Delivery System; Quantum…Spectrum Medical, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020 · cites it directly2descendants
- K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020 · 2 generations on1descendant
- K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…Spectrum Medical, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| −3 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| −2 | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc. | 2000 | — |
| −1 | K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260 | Quest Medical, Inc. | 2004 | 1 |
| 0 (this device) | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | — |
| +1 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +2 | K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +3 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260Summary page 4…MPS2 Myocardial Protection System Console Generic/Common Name: Myocardial Perfusion System PREDICATE DEVICE(S) [807.92(a)(3)] MPS2 Myocardial Protection System Console (K041979) DEVICE DESCRIPTION [807.92(a)(4)] The MPS 2 console is a single device for myocardial perfusion that incorporates several diffe… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200438 | MPS 3 Myocardial Protection System | 2020 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2019 | Class II | Z-2107-2020 | Under Investigation by firm | Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K200438 (Quest Medical, Inc., 2020) has gone furthest, with 2 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. 2018, this device’s year, is highlighted.
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 MPS2 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 heart during open heart surgery on either an arrested or beating heart for use up to six hours in duration.
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/K173716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173716: MPS2 Myocardial Protection System Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173716
Report an extraction error
Are you the manufacturer?
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