# K022913: Nxstage Premixed Dialysate

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Oct 21, 2002 after 48 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: 2 generations back to K864265 (1987). 6 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013655: Nxstage Dialysate Concentrate, Model RFC-100, Nxstage Medical, Inc. (2002)
- K910270: Premixed Dialysate for Hemodiafiltration, Baxter Healthcare Corp (1991) Summary page 1.
- K013448: Prismasate, Gambro Renal Products (2002)

## Most influential descendants
- 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
- K162887: PrismaSATE (2017), 4 descendants of its own

## Indications for use
NxStage Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

Source page: https://510kreport.com/device/K022913
Methodology: https://510kreport.com/methodology