510(k) · Cleared
Recalled · Class I · 2021Affinity 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)
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 18, 2019 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 10 times, including 10 Class I recalls.
- Decided
- Mar 18, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 10 (10 Class I)
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK183511 Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211)…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) | K183511 | Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity… | 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.
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 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 4, 2021 | Class I | Z-1192-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1197-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1196-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1191-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1198-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1199-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1195-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1194-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1190-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Feb 4, 2021 | Class I | Z-1193-2021 | Device Design | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
The 5 latest of 10 recalls; the web page lists all.
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 | — |
What is it indicated for?
The Affinity Pixie™ Oxygenator with Balance™ Biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min. The Affinity Pixie™ Oxygenator with 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 CPB procedures up…
Read the full statement (407 words)
The Affinity Pixie™ Oxygenator with Balance™ Biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie™ Oxygenator with 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie™ Oxygenator with 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie™ 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 Pixie™ Oxygenator with Cortiva™ BioActive Surface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie™ Oxygenator with 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie™ Oxygenator with 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie™ Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K183511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183511: 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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183511
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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