# K952532: Affinity Arterial Blood Filter

- Pathway: 510(k) (Traditional)
- Applicant: Avecor Cardiovascular, Inc.
- Decided: Oct 6, 1995 after 127 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 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
- K994208: Affinity 20 Micron Arterial Blood Filter, Model 353/354 (2000), 8 descendants of its own
- K071253: Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014 (2007), 7 descendants of its own
- K033468: Affinity 20U Arterial Filter with Trillium Biosurface (2003), 7 descendants of its own
- K013084: Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T (2001), 6 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own

## Recalls of this device
- Nov 14, 2019 · Class II · Z-0693-2020: Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

Source page: https://510kreport.com/device/K952532
Methodology: https://510kreport.com/methodology