# K052608: Telephone Based BL Healthcare Remote Care Management System (RCMS)

- Pathway: 510(k) (Traditional)
- Applicant: Bl Healthcare, Inc.
- Decided: Feb 1, 2006 after 132 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: 8 generations back to K864318 (1987). 26 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 32 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.
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 1.
- K001308: Modification to Zymed Telemetry System, Model Easiview, Agilent Technologies (2000)
- K031863: Carestation 126S Videophone, Motion Media Technology, Inc. (2003) Summary page 2.

## Most influential descendants
- K093379: TCX-I-DV Remote Care Management System (2010), 4 descendants of its own
- 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 purpose of the Telephone based BL Healthcare Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, blood glucose, SPO2, FEVI and PEE 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/K052608
Methodology: https://510kreport.com/methodology