# K061103: Haemonetics 40U RBC Filter Bag

- Pathway: 510(k) (Traditional)
- Applicant: Haemonetics Corp.
- Decided: May 17, 2006 after 27 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 K942844 (1996). 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)
- K942844: Level 1 Blood Stream Recovery System, Level 1 Technologies, Inc. (1996) Summary page 1.

## Indications for use
The Haemonetics 40g RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.

Source page: https://510kreport.com/device/K061103
Methodology: https://510kreport.com/methodology