# K013655: Nxstage Dialysate Concentrate, Model RFC-100

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Feb 4, 2002 after 90 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K910270 (1991). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001059: Normocarb Sterile Bicarbonate Renal Dialysis, Novex Pharma (2000) Summary page 1.
- K910270: Premixed Dialysate for Hemodiafiltration, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K022913: Nxstage Premixed Dialysate (2002), 12 descendants of its own
- K033386: Nxstage Pureflow Solution (2003), 10 descendants of its own
- K042045: Nxstage Pureflow-B Solution (2004), 8 descendants of its own
- K072908: Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy (2008), 6 descendants of its own
- K120333: Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy (2012), 5 descendants of its own

## Indications for use
NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

Source page: https://510kreport.com/device/K013655
Methodology: https://510kreport.com/methodology