# K132972: Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 28, 2013 after 35 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K122914 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122914: Affinity Fusion Cardiotomy/Venous Reservior with Balance Biosurface Model BB841, Affinity Fusion Cardiotomy/ Venous Rese, Medtronic, Inc. (2013) Summary page 1.

## 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
- 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 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.

Source page: https://510kreport.com/device/K132972
Methodology: https://510kreport.com/methodology