# K051232: D731 Micro 20 PH.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 PH.I.SI.O Pediatric Arterial Filter

- Pathway: 510(k) (Special)
- Applicant: Dideco S.R.L.
- Decided: May 20, 2005 after 7 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 K002493 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 2.

## Indications for use
The Dideco D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with phosphoryicholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O., with 40 micron screen with phosphoryicholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are 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/K051232
Methodology: https://510kreport.com/methodology