# K040799: Hommed Genesis Patient Monitor System with Options

- Pathway: 510(k) (Traditional)
- Applicant: Hommed, LLC
- Decided: Aug 18, 2004 after 142 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HomMed Sentry III Patient Monitor System with Card Reader: named in the summary without a submission number

## Most influential descendants
- K061087: Genesis Otc Monitor (2006), 48 descendants of its own
- K072698: Confidant 2.5 (2007), 34 descendants of its own
- K101242: Genesis DM Model: 6053000A1 (2010), 18 descendants of its own
- K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0 (2010), 17 descendants of its own
- K113165: Mini-Medic (2012), 13 descendants of its own

## Indications for use
The HomMed Genesis Patient Monitor with Options is a system designed to monitor patient vital signs at home and/or in healthcare facilities. Vital signs include pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products including glucose meter, spirometer, and prothrombin time can be exported via the Genesis communication module. Vital signs data is transmitted via modem to a central viewing station for display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status. HomMed Genesis is intended for use with adult and pediatric patients over twelve years of age. The card reader functionality of HomMed Genesis allows a single patient to use multiple monitors or multiple patients to use a single monitor.

Source page: https://510kreport.com/device/K040799
Methodology: https://510kreport.com/methodology