# K042045: Nxstage Pureflow-B Solution

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Aug 27, 2004 after 28 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864265 (1987). 8 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033386: Nxstage Pureflow Solution, Nxstage Medical, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K233950: pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (2024), 2 descendants of its own

## Recalls of this device
- Mar 18, 2013 · Class II · Z-1214-2013: Product may be mislabeled.

## Indications for use
NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

Source page: https://510kreport.com/device/K042045
Methodology: https://510kreport.com/methodology