# K062215: Confidant 2.0

- Pathway: 510(k) (Special)
- Applicant: Confidant, Inc.
- Decided: Oct 16, 2006 after 76 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). 20 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050929: The Hermes System, Palaistra Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K072698: Confidant 2.5 (2007), 34 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K092635: Alcatel-Lucent Teleheath Manager (2009), 9 descendants of its own
- K113446: Vignet Telehealth Manager (2012), 8 descendants of its own
- K124000: Medapps 2.0 - Remote Patient Monitoring System (2013), 4 descendants of its own

## Indications for use
Confidant 2.0 is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. Confidant 2.0 is to be used only upon prescription of a licensed physician or other authorized healthcare provider. Confidant 2.0 is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Confidant 2.0 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. Confidant 2.0 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Source page: https://510kreport.com/device/K062215
Methodology: https://510kreport.com/methodology