# K122760: Affinity AF100 Arterial Filter with Balance Biosurface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Dec 7, 2012 after 88 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: 3 generations back to K926413 (1993). 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)
- K033468: Affinity 20U Arterial Filter with Trillium Biosurface, Medtronic Perfusion Systems (2003) Summary page 1.

## Indications for use
The AFI 00 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/K122760
Methodology: https://510kreport.com/methodology