# K112858: Genesis Touch System

- Pathway: 510(k) (Traditional)
- Applicant: Honeywell Hommed, LLC
- Decided: Jan 24, 2012 after 116 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: 3 generations back to K040799 (2004). 4 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101242: Genesis DM Model: 6053000A1, Honeywell Hommed, LLC (2010) Summary page 1.

## Most influential descendants
- K122285: Tablet Commander (2012), 5 descendants of its own
- K133252: Healthinterlink Beacon (2014), 3 descendants of its own
- K181248: Comarch e-Care Platform (2018), 2 descendants of its own
- K211822: LifePath Remote Patient Monitoring Platform (2022), 1 descendant of its own
- K130971: Optum Telehealth Application (2013), 1 descendant of its own

## Indications for use
The Honeywell HomMed Genesis Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmited via a communication module to a central viewing station where the data can be viewed and analyzed by a healthcare professional. The Genesis Touch Retrospective Physiological Monitoring System is intended for home use by adult and pediatric patients over twelve years of age or in a healthcare related environment by healthcare providers. The Genesis Touch Retrospective Physiological Monitoring System is not intended for emergency use or real-time monitoring and does not have auditory or visual alarms for out-of-limit parameters.

Source page: https://510kreport.com/device/K112858
Methodology: https://510kreport.com/methodology