510(k) · Cleared
ClearedQuest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical, Inc. · FRN Pump, Infusion
Cleared on May 31, 2000 as substantially equivalent to K953838 (Quest Medical, Inc., 1996) after a 163-day review. Its family tree reaches back 2 generations to 1980. 5 later devices descend from it.
- Decided
- May 31, 2000
- Review
- 163 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K802147 (1980). 7 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK802147 Shiley Temperature MonitorShiley, Inc. · 1980
- 1 generation backK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- This deviceK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK201984 MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
- Descendant · 5 generations on · 0 of its ownK240908 Quantum Micro-Cardioplegia Delivery System; Quantum…Spectrum Medical, Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K041979MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · cites it directly4descendants
- K173716MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · 2 generations on3descendants
- K200438MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020 · 3 generations on2descendants
- K201984MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020 · 4 generations on1descendant
- K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…Spectrum Medical, Ltd. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| −1 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| 0 (this device) | 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 |
| +2 | K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018 | 1 |
| +3 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +4 | K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| +5 | 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 |
|---|---|---|
| 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K953838 | Myocardial Protection SystemSummary page 2…CFR 870.4205 Safety and Effectiveness Substantial Equivalence: This device has been shown to be substantially equivalent to the Quest MPS Myocardial Protection System #k953838 Other Safety and Effectiveness Data Materials: Fluid contact materials are comply with ISO 10993-1 “Biological Evaluation of Me… | 1996 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260 | 2004 | 4 |
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 20 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K041979 (Quest Medical, Inc., 2004) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K953838.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist 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
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/K994274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994274: Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994274
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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