# K101078: BL Healthcare Remote Care Management System

- Pathway: 510(k) (Special)
- Applicant: Bl Healthcare, Inc.
- Decided: May 10, 2010 after 21 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- 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). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052608: Telephone Based BL Healthcare Remote Care Management System (RCMS), Bl Healthcare, Inc. (2006)
- K051470: Remote Care Management Systems (RCMS), Bl Healthcare, Inc. (2005) Summary page 1.
- K093379: TCX-I-DV Remote Care Management System, Bl Healthcare, Inc. (2010) Summary page 1.
- K034046: RNK Telephonic Stethoscope, Model TR-1, Rnk Products (2004) Summary page 1.
- K073038: Carematix Wellness System, Model CWS-5000.1-B, Carematix, Inc. (2008) Summary page 1.

## Most influential descendants
- K113493: TCX-I Remote Care Management System (2011), 0 descendants of its own

## Indications for use
The purpose of the TCx-l Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. The system supports videoconferencing, multimedia education and messages. 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 judgment by an experienced medical professional.

Source page: https://510kreport.com/device/K101078
Methodology: https://510kreport.com/methodology