510(k) Report

510(k) · Cleared

Cleared

Affinity Fusion™ Oxygenator System

K230640510(k) SpecialCleared Apr 6, 202329-day reviewClass II21 CFR 870.4350

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

Medtronic, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass

Cleared on Apr 6, 2023 as substantially equivalent to K203111 (Medtronic, 2021) after a 29-day review. Its family tree reaches back 2 generations to 2019. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Apr 6, 2023
Review
29 days
Class
Class II
Product code
DTZ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K183511 (2019). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2019: 1 other ancestor2024: 1 descendant clearedK183511 · Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) · Medtronic, Inc. · 2019 · Class I recallK203111 · Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System · Medtronic · 2021 · recalled201620182020202220242026
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant K203111 · Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System · Medtronic · 2021 · recalledK183511 · Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) · Medtronic, Inc. · 2019 · Class I recall0
  1. Root · 2 generations backK183511 Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211)…Medtronic, Inc. · 2019 · Recalled (Class I)
  2. 1 generation backK203111 Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic · 2021 · Recalled
  3. This deviceK230640 Affinity Fusion™ Oxygenator SystemMedtronic, Inc. · 2023
  4. Descendant · cites it directly · 0 of its ownK240666 Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems · 2024

Class I recalls in this family

  • K183511 Affinity Pixie™ Oxygenator with Balance™…2 generations back · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic Perfusion Systems · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K183511Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity…Medtronic, Inc.2019Class I
−1K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic20216
0 (this device)K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc.2023—
+1K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance…Medtronic Perfusion Systems2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K230640, 2019–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. 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. #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Summary page 8
…evice Trade Name 510(k) Clearance Date Affinity Fusion Oxygenator K203111 September 16, 2021 No reference devices were used in this submission. Device Description The Affinity Fusion Oxygena…
Medtronic20216

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic Perfusion Systems20240

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K183511Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and…Medtronic, Inc. · 2019 · 2 generations back · ◆ on the line of descent in FIG. 110 Class I recalls

What does this lineage say?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K240666 (Medtronic Perfusion Systems, 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DTZ devices

DTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · DTZ

2in 2025

2007: 42008: 32009: 92010: 22011: 42012: 92013: 92014: 52015: 92016: 32017: 22018: 32019: 52020: 52021: 52022: 22023: 52024: 32025: 22026 (partial year): 3
2007high 9 (2009) · low 2 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTZ

124in 2024

2007: 55 days median2008: 88 days median2009: 210 days median2011: 160 days median2012: 90 days median2013: 28 days median2014: 28 days median2015: 134 days median2016: 62 days median2018: 72 days median2019: 90 days median2020: 93 days median2021: 336 days median2023: 145 days median2024: 124 days median2026 (partial year): 137 days median
2007high 336 (2021) · low 28 (2013)2026

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

Recalls per year · DTZ

1in 2025

2007: 72008: 52010: 12011: 132012: 142014: 22016: 12018: 2, 2 Class I2019: 12020: 32021: 1, 1 Class I2022: 62025: 1
2007high 14 (2012) · low 0 (2009)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DTZ

976in 2025

2007: 1342008: 1052009: 522010: 1192011: 1902012: 2152013: 3462014: 7642015: 6582016: 4432017: 3882018: 3202019: 4892020: 4422021: 5952022: 5592023: 7382024: 5352025: 976
2007high 976 (2025) · low 52 (2009)2025

MAUDE reports naming product code DTZ, 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
20074557134
20083885105
20099210052
20102—1119
2011416013190
201299014215
20139280346
20145282764
201591340658
20163621443
20172—0388
20183722 (2)320
20195901489
20205933442
202153361 (1)595
20222—6559
202351450738
202431240535
20252—1976
202631370—

What is it indicated for?

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance 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. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than…

Read the full statement (521 words)

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance 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.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the

circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass

surgery.

Oxygenator with Integrated Arterial Filter

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance 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.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the

circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass

surgery.

Cardiotomy/Venous Reservoir

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal

perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6

hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart

surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume

replacement.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva 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 (CPB) procedures up to 6 hours in duration.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the

circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

Oxygenator with Integrated Arterial Filter

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva 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 (CPB) procedures up to 6 hours in duration.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the

circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

Cardiotomy/Venous Reservoir

The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal

perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6

hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.

The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery

to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Indications for use as stated in the FDA summary.

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Recent decisions in DTZ

The DTZ category page

  • K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026
  • K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd. · 2026
  • K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3…Spectrum Medical S.R.L. · 2026
  • K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus…Eurosets S.R.L · 2025
  • K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L · 2025

https://510kreport.com/device/K230640 · printed Nov 6, 2026

Cite this page

510(k) Report. “K230640: Affinity Fusion™ Oxygenator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230640

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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