510(k) Report

510(k) · Cleared

Cleared

Cardiotherm Blood Cardioplegia Systems

K960755510(k) TraditionalCleared May 23, 199690-day reviewClass II21 CFR 870.1330

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

Medtronic Cardiac Surgery, Medtronic, Inc. · DQX Wire, Guide, Catheter

Cleared on May 23, 1996 as substantially equivalent to K934355 (Electromedics, Inc., 1993) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.

Decided
May 23, 1996
Review
90 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K896807 (1990). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 2 other ancestors1990: 1 other ancestor1998: 1 descendant cleared2000: 1 descendant cleared1997: 1 descendant clearedK896807 · SPBC Series Single Pass Blood Cardioplegia System · Gish Biomedical, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants K896807 · SPBC Series Single Pass Blood Cardioplegia System · Gish Biomedical, Inc. · 19900
  1. Root · 1 generation backK896807 SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc. · 1990
  2. This deviceK960755 Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
  3. Descendant · cites it directly · 0 of its ownK991137 Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000
  4. Descendant · cites it directly · 0 of its ownK973237 CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998
  5. Descendant · cites it directly · 0 of its ownK973475 Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx…Medtronic Vascular · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000 · cites it directly0descendants
  • K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998 · cites it directly0descendants
  • K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr…Medtronic Vascular · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896807SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc.1990—
0 (this device)K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc.1996—
+1K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp.2000—
+1K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc.1998—
+1K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and…Medtronic Vascular1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199320
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200010
FIG. 1 — Lineage of K960755, 1990–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DQX? 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K934355Electromedics Blood Heat Exchanger
Summary page 1
…Delivery Systems (CTXXX Series and CTXXXBR Series) NAME OF PREDICATE OR LEGALLY MARKETED DEVICE ¢ Medtronic Electromedics, Inc. - Blood Cardioplegia Dielivery Systems (K934355) e Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) e Avecor Cardiovascular - MYOtherm…
Electromedics, Inc.1993—
*K896807SPBC Series Single Pass Blood Cardioplegia System
Summary page 1
…KETED DEVICE ¢ Medtronic Electromedics, Inc. - Blood Cardioplegia Dielivery Systems (K934355) e Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) e Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171) e Sorin Biomedical - BCD ADVANCED Blood C…
Gish Biomedical, Inc.1990—
*K944219Single Pass Blood Cardioplegia SPBC System Components
Summary page 1
…ICE ¢ Medtronic Electromedics, Inc. - Blood Cardioplegia Dielivery Systems (K934355) e Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) e Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171) e Sorin Biomedical - BCD ADVANCED Blood Cardiopleg…
Gish Biomedical, Inc.1995—
*K904171Scimed Cardiotherm Cardioplegia Delivery System
Summary page 1
…K934355) e Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) e Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171) e Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) DESCRIPTION OF DEVICE Each Medtronic CardicTherm™ Blood…
Scimed1990—
*K925369BCD Advanced Blood Carioplegia Systems
Summary page 1
…BC) Systems (K896807/ K944219) e Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171) e Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) DESCRIPTION OF DEVICE Each Medtronic CardicTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix…
Sorin Biomedica, Fiat, USA, Inc.1993—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp.20000
K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc.19980
K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr…Medtronic Vascular19970

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K991137 (Minntech Corp., 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

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

More from Medtronic Cardiac Surgery, Medtronic…

2 FDA decisions under this applicant name. See the company

  • K953564Medtronic Overpressure/Vacuum Relief ValveMedtronic Cardiac Surgery, Medtronic, Inc. · 1996

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https://510kreport.com/device/K960755 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960755: Cardiotherm Blood Cardioplegia Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960755

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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