# K032128: Terumo AL8X Arterial Filter with X-Coating

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Aug 1, 2003 after 22 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: 1 generation back to K834380 (1984). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834380: Pall EC Plus Filter, Pall Biomedical Products Co. (1984) Summary page 1.

## Most influential descendants
- K083834: Terumo Pall AL6X  Arterial Filter (2009), 1 descendant of its own
- K121209: Terumo Pall AL20X Arterial Filter (2012), 0 descendants of its own
- K083747: Terumo Pall AL3X Arterial Filter (2009), 0 descendants of its own

## Indications for use
The Terumo ALSX Arterial Blood Filter for extra-corporeal service is indiiated for use in all cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line. The device may be used in procedures lasting up to 6 hours in duration.

Source page: https://510kreport.com/device/K032128
Methodology: https://510kreport.com/methodology