510(k) · Cleared
Recalled · Class II · 2014Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Jan 22, 2013 as substantially equivalent to K000430 (Medtronic Vascular, 2000) after an 89-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 2013
- Review
- 89 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000430 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000430 Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with…Medtronic Vascular · 2000 · Recalled
- This deviceK123314 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK142784 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK172626 Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion…Medtronic, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000430 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda… | Medtronic Vascular | 2000 | 1 |
| 0 (this device) | K123314 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda… | Medtronic, Inc. | 2013 | — |
| +1 | K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance… | Medtronic, Inc. | 2014 | 1 |
| +2 | K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator… | Medtronic, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DTZ? 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 DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K000430 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive…Summary page 1…DTZ Name of Predicate Device: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioctive Surface Model CB5I11 (K000430) Device Description: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioctive Surface is a single-use… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface… | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2014 | Class II | Z-0531-2015 | Process control | Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda
Bioctive Surface is intended to be used in an extracorporeal perfusion circuit to
oxygenate and remove carbon dioxide from the blood and to cool or warm the
blood during routine cardiopulmonary bypass procedures up to 6 hours in
duration.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda
BioActive Surface is designed to filter from the circuit microemboli larger than the
specified micron size for periods up to six hours during cardiopulmonary bypass
surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123314: Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123314
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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