510(k) · Cleared
ClearedHommed Genesis Patient Monitor System with Options
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hommed, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 18, 2004 after a 142-day review. The FDA summary names its predicate without a number. 67 later devices descend from it.
- Decided
- Aug 18, 2004
- Review
- 142 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 2 citing it directly.
- This deviceK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
- Descendant · cites it directly · 48 of its ownK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
- Descendant · 2 generations on · 34 of its ownK072698 Confidant 2.5Confidant, Inc. · 2007
- Descendant · 2 generations on · 18 of its ownK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
- Descendant · cites it directly · 17 of its ownK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- Descendant · 2 generations on · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K061087Genesis Otc MonitorHoneywell Hommed, LLC · 2006 · cites it directly48descendants
- K072698Confidant 2.5Confidant, Inc. · 2007 · 2 generations on34descendants
- K101242Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010 · 2 generations on18descendants
- K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010 · cites it directly17descendants
- K113165Mini-MedicAthena Gtx · 2012 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040799 | Hommed Genesis Patient Monitor System with Options | Hommed, LLC | 2004 | — |
| +1 | K061087 | Genesis Otc Monitor | Honeywell Hommed, LLC | 2006 | — |
| +2 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| +2 | K101242 | Genesis DM Model: 6053000A1 | Honeywell Hommed, LLC | 2010 | — |
| +1 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
| +2 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | HomMed Sentry III Patient Monitor System with Card Reader Named without a submission number |
What descends from it? (67)
See all 672 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061087 (Honeywell Hommed, LLC, 2006) has gone furthest, with 48 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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…
Read the full statement (149 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040799: Hommed Genesis Patient Monitor System with Options.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040799
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026