510(k) · Cleared
ClearedMYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Feb 23, 2024 as substantially equivalent to K162774 (Medtronic, Inc., 2017) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Feb 23, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971105 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK971105 Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 1997
- 2 generations backK011864 Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular · 2001
- 1 generation backK162958 MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface…Medtronic, Inc. · 2017
- This deviceK240190 MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive…Medtronic · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971105 | Myotherm (TM) XP Cardioplegia Delivery System | Avecor Cardiovascular, Inc. | 1997 | — |
| −2 | K011864 | Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B | Medtronic Vascular | 2001 | — |
| −1 | K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP… | Medtronic, Inc. | 2017 | — |
| 0 (this device) | K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface… | Medtronic | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2017 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…Summary page 5…stem with Cortiva CBXP41 BioActive Surface K162774 MYOtherm XP Cardioplegia Delivery System with Cortiva CBXP41B… | 2017 |
| * | K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP…Summary page 5…MYOtherm XP Cardioplegia Delivery System Uncoated K162958 XP41B MYOtherm XP Cardioplegia Delivery System with Bridge 61399405409 Non-S… | 2017 |
| † | K171979 | Tubing Pack | 2017 |
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 27 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 6 ancestors has 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. 2024, 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 MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump. The MYOtherm XP…
Read the full statement (121 words)
The MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240190: MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240190
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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