# K043436: Nxstage Dialysate Preparation Module, Model NX0269

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Mar 17, 2005 after 94 days
- Product code: FKR (Subsystem, Proportioning)
- 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: 2 generations back to K921456 (1994). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub, Aksys, Ltd. (2002) Summary page 1.
- K994267: Fresenius 2008K, Fresenius Medical Care (2000) Summary page 1.
- K810127: Gambro Bicarbonate Module, BCM-10, Gambro, Inc. (1981) Summary page 1.

## Most influential descendants
- K060296: Nxstage Dialysate Preparation Module (2006), 3 descendants of its own
- K080919: Nxstage Pureflow SL (2008), 2 descendants of its own
- K111174: Nxstage Pureflow SL (2011), 1 descendant of its own
- K140571: Nxstage Pureflow SL (2014), 0 descendants of its own
- K081043: Leak Detection Sensor and Tray Accessory Kit (2008), 0 descendants of its own

## Indications for use
The NxStage Dialysate Preparation 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/K043436
Methodology: https://510kreport.com/methodology