# K100645: Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Sep 14, 2012 after 924 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K936003 (1994). 7 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 12 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.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 1.
- K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface, Medtronic Vascular (1994) Summary page 1.
- K021287: Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT, Medtronic Perfusion Systems (2002) Summary page 1.
- K911789: Minimax (TM) Hardshell Venous Res W/Inte Card Filt, Medtronic Vascular (1991) Summary page 1.
- K831528: Model TP Thermistor Probe, Scimed Life Systems, Inc. (1983) Summary page 1.

## Cited in the summary but kept off the family tree
- K042115: Terumo Capiox RX05 Oxygenator with and without Reservoir. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K141233: Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance Biosuface (2014), 1 descendant of its own
- K172984: Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface (2017), 0 descendants of its own
- K160091: Temperature Probe, Affinity Temperature Probe (2016), 0 descendants of its own
- K123448: Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock Adapter with Carmeda Bioactive (2012), 0 descendants of its own

## Indications for use
Oxygenator: The Affinity Pixie Hollow Fiber Oxygenator with Carmeda BioActive Surface or 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 6 hours in duration. Cardiotomy Venous Reservoir: The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or 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. Temperature Probe: The Affinity Temperature Probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's Instructions for Use. The Temperature Probe is designed for use with a Y5jTM Tele-thermometer to monitor and display temperature.

Source page: https://510kreport.com/device/K100645
Methodology: https://510kreport.com/methodology