510(k) · Cleared
ClearedAffinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
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 Apr 12, 2019 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 116 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK183490 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium…Medtronic, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK203111 Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK230640 Affinity Fusion™ Oxygenator SystemMedtronic, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK240666 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems · 2024
Most influential descendants
Showing 3 of 3 · See all- K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic · 2021 · cites it directly2descendants
- K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc. · 2023 · 2 generations on1descendant
- K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic Perfusion Systems · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface… | Medtronic, Inc. | 2019 | — |
| +1 | K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Medtronic | 2021 | 6 |
| +2 | K230640 | Affinity Fusion™ Oxygenator System | Medtronic, Inc. | 2023 | — |
| +3 | K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance… | Medtronic Perfusion Systems | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | 2021 | 2 |
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, K203111 (Medtronic, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 | — |
https://510kreport.com/device/K183490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183490: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183490
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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