510(k) · Cleared
ClearedGenesis Otc Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Honeywell Hommed, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 9, 2006 as substantially equivalent to K040799 (Hommed, LLC, 2004) after a 52-day review. Its family tree reaches back 1 generation to 2004. 48 later devices descend from it.
- Decided
- Jun 9, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040799 (2004). 48 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
- This deviceK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
- Descendant · cites it directly · 34 of its ownK072698 Confidant 2.5Confidant, Inc. · 2007
- Descendant · cites it directly · 18 of its ownK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
- Descendant · 2 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 2 generations on · 11 of its ownK112858 Genesis Touch SystemHoneywell Hommed, LLC · 2012
- Descendant · 2 generations on · 9 of its ownK092635 Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K072698Confidant 2.5Confidant, Inc. · 2007 · cites it directly34descendants
- K101242Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010 · cites it directly18descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 2 generations on12descendants
- K112858Genesis Touch SystemHoneywell Hommed, LLC · 2012 · 2 generations on11descendants
- K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc. · 2009 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040799 | Hommed Genesis Patient Monitor System with Options | Hommed, LLC | 2004 | — |
| 0 (this device) | K061087 | Genesis Otc Monitor | Honeywell Hommed, LLC | 2006 | — |
| +1 | K072698 | Confidant 2.5 | Confidant, Inc. | 2007 | — |
| +1 | K101242 | Genesis DM Model: 6053000A1 | Honeywell Hommed, LLC | 2010 | — |
| +2 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +2 | K112858 | Genesis Touch System | Honeywell Hommed, LLC | 2012 | — |
| +2 | K092635 | Alcatel-Lucent Teleheath Manager | Alcatel-Lucent Canada, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K040799 | Hommed Genesis Patient Monitor System with OptionsSummary page 1…me: Cardiovascular and Respiratory Devices, Class 1I Product Code: NIBP Measurement System, DXN Predicate Device(s). HomMed Genesis Patient Monitor System K040799 Device Description: The Honeywell HomMed Genesis OTC Monitor System is a vital signs monitoring… | 2004 |
What descends from it? (48)
See all 483 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?
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Honeywell HomMed Genesis OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products extend Genesis OTC Monitor's measurement capabilities. Data from the Genesis OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis OTC Monitor is not intended for emergency use or real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061087: Genesis Otc Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061087
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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