# K242953: KIDS Arterial Filters

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Dec 20, 2024 after 86 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: 4 generations back to K961869 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 6.
- K072308: D131 PH.I.S.I.O Dideco Kids Infant Arterial Filter with 40 Micron Screen Phosphorycholine Coated, Sorin Group Italia S.R.L. (2007) Summary page 6.

## Indications for use
The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.

Source page: https://510kreport.com/device/K242953
Methodology: https://510kreport.com/methodology