# K970225: Alpha Micron 20/40 Microaggregate Filter

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Therapeutic Corp.
- Decided: Feb 14, 1997 after 28 days
- Product code: CAK (Microfilter, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K810761 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955515: Alpha Micron 20 Microaggregate Filter, Alpha Therapeutic Corp. (1996) Summary page 1.
- K810761: Alpha Micron-40 Filter, Alpha Therapeutic Corp. (1981) Summary page 1.

## Indications for use
The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.

Source page: https://510kreport.com/device/K970225
Methodology: https://510kreport.com/methodology