# K111174: Nxstage Pureflow SL

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Sep 19, 2011 after 145 days
- Product code: FKR (Subsystem, Proportioning)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921456 (1994). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080919: Nxstage Pureflow SL, Nxstage Medical, Inc. (2008) Summary page 2.

## Most influential descendants
- K140571: Nxstage Pureflow SL (2014), 0 descendants of its own

## Recalls of this device
- May 14, 2014 · Class II · Z-1854-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1855-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1858-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1857-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1859-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1860-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1856-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- May 14, 2014 · Class II · Z-1861-2014: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
- Dec 14, 2011 · Not classified · Z-0826-2012: Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System

## Indications for use
The NxStage PureFlow SL module is an optional accessory to the NxStage System OneTM that prepares dialysate for use during hemodialysis, as prescribed by the physician.

Source page: https://510kreport.com/device/K111174
Methodology: https://510kreport.com/methodology