510(k) · Cleared
ClearedCarmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Nov 20, 1997 as substantially equivalent to K960755 (Medtronic Cardiac Surgery, Medtronic, Inc., 1996) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Nov 20, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K896807 (1990). 8 ancestors in all, the oldest K891687 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK896807 SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc. · 1990
- 1 generation backK960755 Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
- This deviceK973475 Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx…Medtronic Vascular · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896807 | SPBC Series Single Pass Blood Cardioplegia System | Gish Biomedical, Inc. | 1990 | — |
| −1 | K960755 | Cardiotherm Blood Cardioplegia Systems | Medtronic Cardiac Surgery, Medtronic, Inc. | 1996 | — |
| 0 (this device) | K973475 | Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and… | Medtronic Vascular | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K960755 | Cardiotherm Blood Cardioplegia SystemsSummary page 1…ioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface NAME OF PREDICATE OR LEGALLY MARKETED DEVICE(S) e Medtronic CardioTherm™ Blood Cardioplegia Systems (K960755) e Medtronic Extracorporeal Circuit with Carmeda® BioActive Surface (K891687) e Medtronic MAXIMA PLUS® PRF Hollow Fiber Oxygen… | 1996 |
| * | K891687 | Extracorporeal Circuit with Bio-Active SurfaceSummary page 1…DICATE OR LEGALLY MARKETED DEVICE(S) e Medtronic CardioTherm™ Blood Cardioplegia Systems (K960755) e Medtronic Extracorporeal Circuit with Carmeda® BioActive Surface (K891687) e Medtronic MAXIMA PLUS® PRF Hollow Fiber Oxygenator with Carmeda® BioActive Surface (K941473) DESCRIPTION OF DEVICE The Medt… | 1989 |
| * | K941473 | Maxima Plus Hollow Fiber OxygenatorSummary page 1…55) e Medtronic Extracorporeal Circuit with Carmeda® BioActive Surface (K891687) e Medtronic MAXIMA PLUS® PRF Hollow Fiber Oxygenator with Carmeda® BioActive Surface (K941473) DESCRIPTION OF DEVICE The Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is coated with a no… | 1995 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K960755.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Medtronic CardioTherm™ Blood Cardioplegia System, with or without Carmeda® BioActive Surface, is intended for use in procedures requiring the 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.
https://510kreport.com/device/K973475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973475: Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973475
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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