510(k) · Cleared
ClearedMYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Feb 1, 2017 as substantially equivalent to K011864 (Medtronic Vascular, 2001) and 1 other predicate after a 100-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Feb 1, 2017
- Review
- 100 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971105 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK971105 Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 1997
- 1 generation backK011864 Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular · 2001
- This deviceK162958 MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface…Medtronic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK240190 MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive…Medtronic · 2024
Most influential descendants
Showing 1 of 1 · See all- K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…Medtronic · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971105 | Myotherm (TM) XP Cardioplegia Delivery System | Avecor Cardiovascular, Inc. | 1997 | — |
| −1 | K011864 | Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B | Medtronic Vascular | 2001 | — |
| 0 (this device) | K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP… | Medtronic, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K011864 | Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BSummary page 5…y System Classification: Class II Panel: Cardiovascular Regulation: 21 CFR 870.4240 Product Code: DTR Predicate Devices: K011864 – Trillium MYOtherm XP Cardioplegia Delivery System (with or without Bridge); K971105 - MYOtherm XP Cardiopleg… | 2001 |
| * | K971105 | Myotherm (TM) XP Cardioplegia Delivery SystemSummary page 5….4240 Product Code: DTR Predicate Devices: K011864 – Trillium MYOtherm XP Cardioplegia Delivery System (with or without Bridge); K971105 - MYOtherm XP Cardioplegia Delivery System (with or without Bridge) Device Description The MYOtherm XP cardi… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP… | 2024 | 0 |
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 3 companies; a new generation was cleared every 15.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K240190 (Medtronic, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K011864.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
MYOtherm XP Cardioplegia Delivery System Models XP41 and XP41B (uncoated) - 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…
Read the full statement (145 words)
MYOtherm XP Cardioplegia Delivery System Models XP41 and XP41B (uncoated) -
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.
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface Models XP41T and XP41BT -
The MYOtherm XP system with Trillium biosurface 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/K162958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162958: MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162958
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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