510(k) · Cleared
ClearedGenesis DM Model: 6053000A1
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 11, 2010 as substantially equivalent to K061087 (Honeywell Hommed, LLC, 2006) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 2004. 18 later devices descend from it.
- Decided
- Jun 11, 2010
- Review
- 39 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K040799 (2004). 3 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
- 1 generation backK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
- This deviceK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
- Descendant · cites it directly · 11 of its ownK112858 Genesis Touch SystemHoneywell Hommed, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK122285 Tablet CommanderCardiocom, LLC · 2012
- Descendant · 2 generations on · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · cites it directly · 3 of its ownK103214 M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K112858Genesis Touch SystemHoneywell Hommed, LLC · 2012 · cites it directly11descendants
- K122285Tablet CommanderCardiocom, LLC · 2012 · 2 generations on5descendants
- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · 2 generations on3descendants
- K103214M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc. · 2010 · cites it directly3descendants
- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040799 | Hommed Genesis Patient Monitor System with Options | Hommed, LLC | 2004 | — |
| −1 | K061087 | Genesis Otc Monitor | Honeywell Hommed, LLC | 2006 | — |
| 0 (this device) | K101242 | Genesis DM Model: 6053000A1 | Honeywell Hommed, LLC | 2010 | — |
| +1 | K112858 | Genesis Touch System | Honeywell Hommed, LLC | 2012 | — |
| +2 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| +2 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +1 | K103214 | M3810A Philips Telemonitoring System with Edevice BRIDGED130 | Lifeline Systems, Inc. | 2010 | — |
| +3 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2017 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K061087 | Genesis Otc MonitorSummary page 1…Fax: (262) 252-6119 Trade Name: Genesis DM Monitor Predicate Device: HomMed Genesis OTC, K061087 Omron Automatic Blood Pressure Monitor Model:HEM-780N3, K061822 Common Name:… | 2006 |
| * | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3Summary page 1…s DM Monitor Predicate Device: HomMed Genesis OTC, K061087 Omron Automatic Blood Pressure Monitor Model:HEM-780N3, K061822 Common Name: Patient Vital Signs Monitor Classification Name: 8… | 2006 |
What descends from it? (18)
See all 185 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112858 (Honeywell Hommed, LLC, 2012) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K061087.
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. 2010, this device’s year, is highlighted.
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 DM 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 DM Monitor's measurement capabilities. Data from the Genesis DM Monitor can be transmitted via a communication module to a central viewing station for display. The Genesis DM Monitor is not intended for emergency use or real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101242: Genesis DM Model: 6053000A1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101242
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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