# CAK: Microfilter, Blood Transfusion

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 36
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1988: 3
- 1989: 1
- 1990: 6
- 1996: 2
- 1997: 2
- 1998: 1
- 1999: 1
- 2000: 1
- 2002: 1
- 2006: 1

## Most-cited predicates
- K955515: Alpha Micron 20 Microaggregate Filter (1996), cited by 1
- K810761: Alpha Micron-40 Filter (1981), cited by 1
- K022477: Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD Transfusion Filter with Administration Set (2002), cited by 1
- K811985: Ultipor SQ40S Blood Transfusion Filter (1981), cited by 1
- K960993: Pall SQ40S Blood Filter (SQ40S/SQ40ST) (1996), cited by 1
- K830057: 20 Micron High Capacity Trans/Filter (1983), cited by 1

Source page: https://510kreport.com/product-code/CAK
Data by year (CSV): https://510kreport.com/product-code/CAK.csv