# K131739: Nxstage Connected Health System

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Oct 10, 2013 after 119 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: 10 generations back to K864318 (1987). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093379: TCX-I-DV Remote Care Management System, Bl Healthcare, Inc. (2010) Summary page 2.

## Most influential descendants
- K181991: NxStage Connected Health System (2018), 0 descendants of its own

## Indications for use
The NxStage Connected Health System is for use by chronic hemodialysis patients remotely in combination with the NxStage System One and a variety of devices such as blood pressure monitor and weight scale upon the prescription of a licensed physician or healthcare practitioner. The Connected Health System serves as the data repository and communication link to the server software which is utilized by the healthcare facility. The healthcare facility may include the physician or licensed healthcare practitioner, other clinicians, or a disease management center. The purpose of the system is to collect, accumulate, store and transmit medical information such as flowsheet data, vital signs, blood pressure, weight and dialysis data from the patient on the completion of their dialysis treatment and transmit these results to their healthcare practitioner at another facility. The system also provides online labeling, treatment status, trending and supports education and messaging. The device is not intended to provide time sensitive data or alarms and does not control the System One Cycler. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.

Source page: https://510kreport.com/device/K131739
Methodology: https://510kreport.com/methodology