# K142784: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 24, 2014 after 28 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973760 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122827: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model BB811, Medtronic, Inc. (2012) Summary page 5.
- K123314: Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface, Medtronic, Inc. (2013) Summary page 5.

## Most influential descendants
- K172626: Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir (2017), 0 descendants of its own

## Recalls of this device
- Nov 16, 2016 · Class II · Z-0826-2017: Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combinati

## Indications for use
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 six 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. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active 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 six hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bio-Active Surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K142784
Methodology: https://510kreport.com/methodology