# K130460: Nxstage Dosing Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Jul 11, 2013 after 139 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- 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: 1 generation back to K955423 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955423: Pack H Hemodialysis Urea Kinetic Modeling Software Program, Fresenius USA, Inc. (1996) Summary page 2.

## Indications for use
The NxStage Dosing Calculator is intended to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.

Source page: https://510kreport.com/device/K130460
Methodology: https://510kreport.com/methodology