# K092635: Alcatel-Lucent Teleheath Manager

- Pathway: 510(k) (Traditional)
- Applicant: Alcatel-Lucent Canada, Inc.
- Decided: Sep 10, 2009 after 14 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). 24 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 2.
- K072698: Confidant 2.5, Confidant, Inc. (2007) Summary page 2.

## Most influential descendants
- K113446: Vignet Telehealth Manager (2012), 8 descendants of its own
- K122458: Verizon Wireless Remote Health Management System (2013), 2 descendants of its own
- K123671: Wellaho Personalized Outpatient Management System (2013), 2 descendants of its own
- K130971: Optum Telehealth Application (2013), 1 descendant of its own
- K171406: Optum TeleHealth Application (2017), 0 descendants of its own

## Indications for use
Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner. The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements. The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform, which stores the information and allows its remote access by the patient and/or health care professional. Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional.

Source page: https://510kreport.com/device/K092635
Methodology: https://510kreport.com/methodology