# K141792: Genesis Touch System

- Pathway: 510(k) (Traditional)
- Applicant: Honeywell Hommed
- Decided: Nov 25, 2014 after 146 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: 4 generations back to K040799 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 4.
- K112858: Genesis Touch System, Honeywell Hommed, LLC (2012) Summary page 4.

## 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, temperature, blood sugar, prothrombin time/international normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1). The Genesis Touch Retrospective Physiological Monitoring System collects; displays and transmits vital signs measurements from commercially available medical devices designed for home use. Collected measurement data from the Genesis Touch System can then be transmitted 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 patients and caregivers 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/K141792
Methodology: https://510kreport.com/methodology