# K033386: Nxstage Pureflow Solution

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Nov 26, 2003 after 34 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: 3 generations back to K864265 (1987). 7 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022913: Nxstage Premixed Dialysate, Nxstage Medical, Inc. (2002)

## Most influential descendants
- 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
- K233159: pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (2023), 3 descendants of its own

## Indications for use
The NxStage Pureflow Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

Source page: https://510kreport.com/device/K033386
Methodology: https://510kreport.com/methodology