# K072308: D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen Phosphorycholine Coated

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Sep 12, 2007 after 26 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 K961869 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002493: Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial Filter, Cobe Cardiovascular, Inc. (2000) Summary page 1.
- K033987: D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters, Dideco S.P.A. (2004) Summary page 1.
- K063255: D130 PH.I.S.I.O Dideco Kids Neonatal Arterial Filter with 40 Micron Screen Phosphorylcholine Coated, Sorin Group Italia S.R.L. (2007) Summary page 1.

## Most influential descendants
- K242953: KIDS Arterial Filters (2024), 0 descendants of its own

## Indications for use
D131 Dideco Kids with 40 micron screen phosphorylcholine (Ph.I.S.I.O.) coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filter is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Source page: https://510kreport.com/device/K072308
Methodology: https://510kreport.com/methodology