# K031099: Sorb+Hisorb+Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Renal Solutions, Inc.
- Decided: Sep 17, 2003 after 163 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: 1 generation back to K811170 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811170: D-3160 Sorbent Cartridge, Organon Teknika Corp. (1981) Summary page 1.
- K812869: D-3260 Sorbent Cartridge, Organon Teknika Corp. (1981) Summary page 1.

## Indications for use
The SORB+ and HISORB+ Cartridges are to be used only with Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

Source page: https://510kreport.com/device/K031099
Methodology: https://510kreport.com/methodology