# K070222: Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610N

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Apr 24, 2007 after 90 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924437 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003498: Fresenius Optiflux 200A, Fresenius Medical Care North America (2001) Summary page 2.
- K980386: Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0), Gambro Healthcare (1999) Summary page 2.
- K032431: Prisma M60/M100 Sets, Gambro, Inc. (2003) Summary page 2.

## Indications for use
Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies. The RAC 100 Filter is intended for use in the following continuous veno-venous therapies: * continuous veno-venous hemofiltration (CVVH) * continuous veno-venous hemodialysis (CVVHD) The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.

Source page: https://510kreport.com/device/K070222
Methodology: https://510kreport.com/methodology