# K051470: Remote Care Management Systems (RCMS)

- Pathway: 510(k) (Traditional)
- Applicant: Bl Healthcare, Inc.
- Decided: Jun 8, 2005 after 5 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: 7 generations back to K864318 (1987). 19 ancestors in all.
21 later devices descend from it; 9 cite 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)
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B), Philips Medical Systems (2002) Summary page 2.
- K031840: Carematix Wellness System, Carematix, Inc. (2003) Summary page 2.
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 2.
- K011779: Avidcare Series 100 Telemanagement System, Avid Care Corp. (2001) Summary page 2.
- K010029: Home Health Monitoring System, Avid Care Corp. (2001) Summary page 2.
- K981533: Aviva Systems Model Numbers 1010, 2020, American Telecare, Inc. (1998) Summary page 2.

## Most influential descendants
- K071564: Motiva Monitor Device Connectivity, Model# 453564036921 (2007), 5 descendants of its own
- K052608: Telephone Based BL Healthcare Remote Care Management System (RCMS) (2006), 5 descendants of its own
- K093379: TCX-I-DV Remote Care Management System (2010), 4 descendants of its own
- K091579: Foresee Home (2009), 4 descendants of its own
- K121738: Myvisiontrack (TM) (2013), 3 descendants of its own

## Indications for use
The BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare 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 blood glucose 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/K051470
Methodology: https://510kreport.com/methodology