# K060381: Allient Sorbet Hemodialysis System, Model 1100

- Pathway: 510(k) (Special)
- Applicant: Renal Solutions, Inc.
- Decided: May 24, 2006 after 99 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: 2 generations back to K840743 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043574: Allient Sorbent Hemodialysis System, Model 1000, Renal Solutions, Inc. (2005) Summary page 2.

## Indications for use
The Allient Sorbent Hemodialysis System, including the SORB series and HISORB series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.

Source page: https://510kreport.com/device/K060381
Methodology: https://510kreport.com/methodology