# K093362: 2008 Hemodialysis Sorbent System

- Pathway: 510(k) (Abbreviated)
- Applicant: Renal Solutions, Inc.
- Decided: Aug 13, 2010 after 289 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: 3 generations back to K921456 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070739: Allient Sorbent Hemodialysis System, Model# 1500, Renal Solutions, Inc. (2007) Summary page 3.
- K080964: Fresenius Model 2008T Hemodialysis Machine, Fresenius Medical Care North America (2009) Summary page 3.

## Most influential descendants
- K123835: 2008 Hemodialysis Sorbent System (2013), 0 descendants of its own

## 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/K093362
Methodology: https://510kreport.com/methodology