# K251744: Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

- Pathway: 510(k) (Special)
- Applicant: Medtronic
- Decided: Jan 16, 2026 after 224 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
Longest line of descent: 2 generations back to K943917 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100646: Affinity Pixie Arterial Filter with Balance Biosurface, Medtronic, Inc. (2010) Summary page 7.
- K071253: Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014, Medtronic Vascular (2007) Summary page 7.

## Indications for use
The Affinity® Pediatric Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli. The Affinity Pixie™ Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Source page: https://510kreport.com/device/K251744
Methodology: https://510kreport.com/methodology