# K123314: Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jan 22, 2013 after 89 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: 1 generation back to K000430 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000430: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive Surface, Model CB511, Medtronic Vascular (2000) Summary page 1.

## Most influential descendants
- K142784: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface (2014), 1 descendant of its own
- 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
- Oct 31, 2014 · Class II · Z-0531-2015: Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this iss

## Indications for use
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioctive 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. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive 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/K123314
Methodology: https://510kreport.com/methodology