510(k) · Cleared
ClearedAffinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda 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 Mar 25, 2015 as substantially equivalent to K932252 (Avecor Cardiovascular, Inc., 1993) and 2 other predicates after a 149-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Mar 25, 2015
- Review
- 149 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K932252 (1993). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- This deviceK143073 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium…Medtronic, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK162896 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium…Medtronic, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK162016 Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc. · 2016
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 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| 0 (this device) | K143073 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface… | Medtronic, Inc. | 2015 | — |
| +1 | K162896 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface | Medtronic, Inc. | 2016 | — |
| +1 | K162016 | Affinity NT Oxygenator with Cortiva BioActive Surface | Medtronic, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K932252 | Affinity Hollow Fiber OxygenatorSummary page 4…: Cardiovascular Regulation Number: 21 CFR 870.4350 Product Code: DTZ Classification: Class II Predicate Devices Medtronic Affinity Oxygenator (K932252) Medtronic Affinity Oxygenator with Trillium Biosurface (K973760) Medtronic Affinity Oxygenator with Carmeda BioActive Surface (K… | 1993 |
| * | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceSummary page 4…t Code: DTZ Classification: Class II Predicate Devices Medtronic Affinity Oxygenator (K932252) Medtronic Affinity Oxygenator with Trillium Biosurface (K973760) Medtronic Affinity Oxygenator with Carmeda BioActive Surface (K000430) Device Description The Medtronic Affinity NT Hollow Fibe… | 1998 |
| * | K000430 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive…Summary page 4…es Medtronic Affinity Oxygenator (K932252) Medtronic Affinity Oxygenator with Trillium Biosurface (K973760) Medtronic Affinity Oxygenator with Carmeda BioActive Surface (K000430) Device Description The Medtronic Affinity NT Hollow Fiber Oxygenator is a single use gas exchange device with plasma resistant… | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Model 511: The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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. Model CB511: The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda BioActive Surface is intended to be used in an extracorporeal…
Read the full statement (154 words)
Model 511:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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.
Model CB511:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda BioActive 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.
Model 511T:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Trillium Biosurface 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143073: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143073
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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