# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Mar 18, 2019 after 90 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 10 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K203111: Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System (2021), 2 descendants of its own
- K230640: Affinity Fusion™ Oxygenator System (2023), 1 descendant of its own
- K240666: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) (2024), 0 descendants of its own

## Recalls of this device
- Feb 4, 2021 · Class I · Z-1192-2021: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K183511
Methodology: https://510kreport.com/methodology