510(k) · Cleared
ClearedQuantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Ltd. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Jul 8, 2025 as substantially equivalent to K201984 (Quest Medical, Inc., 2020) after a 462-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Jul 8, 2025
- Review
- 462 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K802147 (1980). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK802147 Shiley Temperature MonitorShiley, Inc. · 1980
- 6 generations backK953838 Myocardial Protection SystemQuest Medical, Inc. · 1996 · Recalled
- 5 generations backK994274 Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)Quest Medical, Inc. · 2000
- 4 generations backK041979 MPS Myocardial Protection System - MPS 2 Console, Model 5201260Quest Medical, Inc. · 2004 · Recalled
- 3 generations backK173716 MPS2 Myocardial Protection System ConsoleQuest Medical, Inc. · 2018 · Recalled
- 2 generations backK200438 MPS 3 Myocardial Protection SystemQuest Medical, Inc. · 2020
- 1 generation backK201984 MPS 3 ND Myocardial Protection SystemQuest Medical, Inc. · 2020
- This deviceK240908 Quantum Micro-Cardioplegia Delivery System; Quantum…Spectrum Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| −6 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| −5 | K994274 | Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc. | 2000 | — |
| −4 | 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 |
| −2 | K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| −1 | K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020 | — |
| 0 (this device) | 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 |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201984 | MPS 3 ND Myocardial Protection SystemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201984 MPS3 ND Myocardial Protection System DTR K1231… | 2020 |
| Kept off the family tree | K001231 | FDA’s K001231 is The Kalix Implant Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 12 ancestors have a recall of any class.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Quantum Micro-Cardioplegia Delivery System is intended for delivery of micro-cardioplegia to the heart during open heart surgery lasting up to six hours in duration. It is intended to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240908: Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240908
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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