# K083747: Terumo Pall AL3X Arterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Aug 20, 2009 after 246 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011804: Capiox Arterial Filter with X-Coating, Product Code CX*AFO2X, Terumo Cardiovascular Systems Corp. (2001)
- K032128: Terumo AL8X Arterial Filter with X-Coating, Terumo Cardiovascular Systems Corp. (2003)

## Indications for use
The Terumo Pall AL3X Pediatric Arterial Filter is indicated for use in 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 and where the flow rate will not exceed 3 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.

Source page: https://510kreport.com/device/K083747
Methodology: https://510kreport.com/methodology