# K050929: The Hermes System

- Pathway: 510(k) (Traditional)
- Applicant: Palaistra Systems, Inc.
- Decided: May 20, 2005 after 36 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.
45 later devices descend from it; 3 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041816: RTX3320PSTN Wireless Telehealth Gateway, Rtx Healthcare A/S (2004) Summary page 1.
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 1.

## Most influential descendants
- K062215: Confidant 2.0 (2006), 35 descendants of its own
- K072698: Confidant 2.5 (2007), 34 descendants of its own
- K062377: Medapps Remote Patient Monitoring, Model MA 100 (2007), 20 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

## Indications for use
The Hermes System 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. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider. The Hermes System 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. Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up. data management, and message delivery capabilities. Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hernias can send email to the patient's doctor and/or guardian if good habits are not maintained. The Hermes System 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. Hermes is not intended to provide automated treatment decisions, nor 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/K050929
Methodology: https://510kreport.com/methodology