# K093379: TCX-I-DV Remote Care Management System

- Pathway: 510(k) (Traditional)
- Applicant: Bl Healthcare, Inc.
- Decided: Feb 9, 2010 after 103 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864318 (1987). 34 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051470: Remote Care Management Systems (RCMS), Bl Healthcare, Inc. (2005) Summary page 1.
- K052608: Telephone Based BL Healthcare Remote Care Management System (RCMS), Bl Healthcare, Inc. (2006) Summary page 1.
- K062377: Medapps Remote Patient Monitoring, Model MA 100, Medapps, Inc. (2007) Summary page 1.
- K083158: Exalis, Software Version 1.15, Gambro, Inc. (2009) Summary page 1.

## Most influential descendants
- K131739: Nxstage Connected Health System (2013), 1 descendant of its own
- K101078: BL Healthcare Remote Care Management System (2010), 1 descendant of its own
- K181991: NxStage Connected Health System (2018), 0 descendants of its own
- K113493: TCX-I Remote Care Management System (2011), 0 descendants of its own

## Indications for use
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center. The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. This system is installed by or with support from trained professionals. This device is not intended to provide time sensitive data or alarms. 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 judgement by an experienced medical professional.

Source page: https://510kreport.com/device/K093379
Methodology: https://510kreport.com/methodology