# K053286: Modification to: Nxstage Pureflow-B Solution

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Dec 22, 2005 after 27 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K864265 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042045: Nxstage Pureflow-B Solution, Nxstage Medical, Inc. (2004) Summary page 2.

## Recalls of this device
- Apr 28, 2025 · Class II · Z-1864-2025: Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the 
- May 14, 2024 · Class II · Z-2160-2024: The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution ha
- Apr 11, 2019 · Class II · Z-1707-2019: Certain lots were mislabeled with incorrect product number.
- Apr 11, 2019 · Class II · Z-1706-2019: Certain lots were mislabeled with incorrect product number.
- Oct 17, 2018 · Class II · Z-0501-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0507-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0500-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0505-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0506-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0502-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0503-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Oct 17, 2018 · Class II · Z-0504-2019: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
- Nov 10, 2017 · Class II · Z-1132-2018: Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one 
- Jan 24, 2014 · Class II · Z-1073-2014: Mislabeled product.

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

Source page: https://510kreport.com/device/K053286
Methodology: https://510kreport.com/methodology