# K242092: MICRO Arterial Filters

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Nov 18, 2024 after 124 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 K961869 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952270: Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen, Sorin Biomedical, Inc. (1995) Summary page 6.
- K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter, Cobe Cardiovascular, Inc. (2004) Summary page 6.
- K041061: D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters, Dideco S.P.A. (2004) Summary page 6.
- K112525: D731 Micro 27 PH.I.S.I.O. and D733 Micro 40 PH.I.S.O. Arterial Filters, Parexel International (2011) Summary page 6.
- K961869: Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40, Sorin Biomedical, Inc. (1996) Summary page 6.
- K033987: D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial Filters, Dideco S.P.A. (2004) Summary page 6.

## Indications for use
The devices are recommended for use on 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 may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.

Source page: https://510kreport.com/device/K242092
Methodology: https://510kreport.com/methodology