# K140571: Nxstage Pureflow SL

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: May 15, 2014 after 70 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: 6 generations back to K921456 (1994). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111174: Nxstage Pureflow SL, Nxstage Medical, Inc. (2011) Summary page 3.

## Recalls of this device
- Jan 29, 2018 · Class II · Z-0811-2018: May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
- 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

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

Source page: https://510kreport.com/device/K140571
Methodology: https://510kreport.com/methodology