# K100646: Affinity Pixie Arterial Filter with Balance Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Dec 16, 2010 after 286 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface (2012), 7 descendants of its own
- K122811: Connector Components with Balance Biosurface (2012), 5 descendants of its own
- K151523: Uncoated Tubing and Connector Components (2015), 4 descendants of its own
- K171308: Tubing Pack (2017), 3 descendants of its own
- K171979: Tubing Pack (2017), 2 descendants of its own

Source page: https://510kreport.com/device/K100646
Methodology: https://510kreport.com/methodology