510(k) · Cleared
ClearedMPS 3 Myocardial 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 Jun 19, 2020 as substantially equivalent to K173716 (Quest Medical, Inc., 2018) after a 116-day review. Its family tree reaches back 5 generations to 1980. 2 later devices descend from it.
- Decided
- Jun 19, 2020
- Review
- 116 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K802147 (1980). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK802147 Shiley Temperature MonitorShiley, Inc. · 1980
- 4 generations backK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- 3 generations backK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- 2 generations backK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- 1 generation backK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- This deviceK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK201984 MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK240908 Quantum Micro-Cardioplegia Delivery System; Quantum…Spectrum Medical, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| −4 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| −3 | 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 |
| −1 | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | 1 |
| 0 (this device) | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +1 | K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +2 | 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 | 1 | 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 |
|---|---|---|---|
| * | K173716 | MPS2 Myocardial Protection System ConsoleSummary page 5…Page 1 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] Quest Medical, Inc., MPS®2 Myocardial Protection System (K173716). DEVICE DESCRIPTION [807.92(a)(4)] The MPS 3 Myocardial Protection System (MPS 3) is a software controlled system designed to a… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201984 | MPS 3 ND Myocardial Protection System | 2020 | 1 |
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?
- The line of descent spans 40 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K201984 (Quest Medical, Inc., 2020) has gone furthest, with 1 descendant 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. 2020, 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 3 Myocardial Protection System, consisting of the MPS 3 Console, the MPS 3 Controller, and the MPS 3 Disposables (MPS 3 Delivery Set and optional Accessories) 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/K200438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200438: MPS 3 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/K200438
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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