# K040074: Oneview Interface

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Apr 8, 2004 after 85 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 K921456 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921456: Fresenius 3008/FDS-08 Dialysate Delivery System, Fresenius USA, Inc. (1994) Summary page 1.
- K021060: Fresenius Icare Monitoring System, Fresenius Medical Care North America (2002) Summary page 1.

## Most influential descendants
- K133547: Nxstage System One with Nxview (2014), 1 descendant of its own
- K252377: NxStage System One with NxView (2026), 0 descendants of its own

## Indications for use
OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access. OneView is contraindicated as the sole method of monitoring a patient during treatment,

Source page: https://510kreport.com/device/K040074
Methodology: https://510kreport.com/methodology