# K123835: 2008 Hemodialysis Sorbent System

- Pathway: 510(k) (Special)
- Applicant: Renal Solutions, Inc.
- Decided: Feb 15, 2013 after 64 days
- Product code: FKT (System, Dialysate Delivery, Sorbent Regenerated)
- Device class: 2
- Regulation: 21 CFR 876.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921456 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093362: 2008 Hemodialysis Sorbent System, Renal Solutions, Inc. (2010) Summary page 1.

## Indications for use
The 2008 Sorbent System is Intended for adult acute and chronic uremic patients In the presence of a healthcare practitioner where hemodialysis Is prescribed on the order of a physician.

Source page: https://510kreport.com/device/K123835
Methodology: https://510kreport.com/methodology