510(k) Report

510(k) · Cleared

Cleared

Myotherm (TM) XP Cardioplegia Delivery System

K971105510(k) TraditionalCleared Jul 11, 1997107-day reviewClass II21 CFR 870.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Avecor Cardiovascular, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Jul 11, 1997 after a 107-day review. The FDA summary names no predicate by number. 9 later devices descend from it.

Decided
Jul 11, 1997
Review
107 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2017: 1 descendant cleared2011: 1 descendant cleared2024: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971105 Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc. · 1997
  2. Descendant · cites it directly · 8 of its ownK011864 Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular · 2001
  3. Descendant · 2 generations on · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
  4. Descendant · 3 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
  5. Descendant · 4 generations on · 2 of its ownK140165 MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula…Medtronic, Inc. · 2014
  6. Descendant · 5 generations on · 1 of its ownK251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2001: 12011: 12012: 12014: 12017: 12024: 12025: 12026: 2
2001high 2 (2026) · low 0 (2002)2026

Most influential descendants

Showing 5 of 9 · See all
  • K011864Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular · 2001 · cites it directly8descendants
  • K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · 2 generations on5descendants
  • K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 3 generations on4descendants
  • K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc. · 2014 · 4 generations on2descendants
  • K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971105Myotherm (TM) XP Cardioplegia Delivery SystemAvecor Cardiovascular, Inc.1997—
+1K011864Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular2001—
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…Medtronic, Inc.2011—
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…Medtronic, Inc.20122
+4K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall…Medtronic, Inc.2014—
+5K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201110
201210
201410
201710
202410
202510
202620
FIG. 1 — Lineage of K971105, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DTN? 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 DTN device

  1. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011864Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-BMedtronic Vascular20018
K162958MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP…Medtronic, Inc.20171

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?

  • Of its descendants, K011864 (Medtronic Vascular, 2001) has gone furthest, with 8 descendants of its own.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

What is it indicated for?

The AVECOR 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. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Avecor Cardiovascular, Inc.

9 FDA decisions under this applicant name. See the company

  • K973760Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceAvecor Cardiovascular, Inc. · 19982 recalls
  • K964017Affinity Blood Pump SystemAvecor Cardiovascular, Inc. · 1997
  • K952532Affinity Arterial Blood FilterAvecor Cardiovascular, Inc. · 19951 recall
  • K940126Avecor Pre-Bypass FilterAvecor Cardiovascular, Inc. · 1994
  • K936003Affinity CVRAvecor Cardiovascular, Inc. · 19943 recalls

Recent decisions in DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K971105 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971105: Myotherm (TM) XP Cardioplegia Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971105

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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