510(k) · Cleared
ClearedGenesis Touch System
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 Jan 24, 2012 as substantially equivalent to K101242 (Honeywell Hommed, LLC, 2010) after a 116-day review. Its family tree reaches back 3 generations to 2004. 11 later devices descend from it.
- Decided
- Jan 24, 2012
- Review
- 116 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040799 (2004). 4 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
- 2 generations backK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
- 1 generation backK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
- This deviceK112858 Genesis Touch SystemHoneywell Hommed, LLC · 2012
- Descendant · cites it directly · 5 of its ownK122285 Tablet CommanderCardiocom, LLC · 2012
- Descendant · cites it directly · 3 of its ownK133252 Healthinterlink BeaconHealthinterlink, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK181248 Comarch e-Care PlatformComarch Healthcare SA · 2018
- Descendant · 3 generations on · 1 of its ownK211822 LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022
- Descendant · cites it directly · 1 of its ownK130971 Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K122285Tablet CommanderCardiocom, LLC · 2012 · cites it directly5descendants
- K133252Healthinterlink BeaconHealthinterlink, LLC · 2014 · cites it directly3descendants
- K181248Comarch e-Care PlatformComarch Healthcare SA · 2018 · 2 generations on2descendants
- K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated · 2022 · 3 generations on1descendant
- K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc. · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040799 | Hommed Genesis Patient Monitor System with Options | Hommed, LLC | 2004 | — |
| −2 | K061087 | Genesis Otc Monitor | Honeywell Hommed, LLC | 2006 | — |
| −1 | K101242 | Genesis DM Model: 6053000A1 | Honeywell Hommed, LLC | 2010 | — |
| 0 (this device) | K112858 | Genesis Touch System | Honeywell Hommed, LLC | 2012 | — |
| +1 | K122285 | Tablet Commander | Cardiocom, LLC | 2012 | — |
| +1 | K133252 | Healthinterlink Beacon | Healthinterlink, LLC | 2014 | — |
| +2 | K181248 | Comarch e-Care Platform | Comarch Healthcare SA | 2018 | — |
| +3 | K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | 2022 | — |
| +1 | K130971 | Optum Telehealth Application | Optumhealth Care Solutions, Inc. | 2013 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K101242 | Genesis DM Model: 6053000A1Summary page 1…Date: 09/27/2011 (2) Trade Name: Honeywell HomMed Genesis Touch System (3) Predicate Device: Honeywell HomMed Genesis DM, K10 1242 Common Name: Patient Vital Signs Monitor Classification Name: ____ ___… | 2010 |
What descends from it? (11)
See all 115 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 8 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122285 (Cardiocom, LLC, 2012) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K101242.
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. 2012, 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 Touch Retrospective Physiological Monitoring System is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse oximetry, pulse rate, weight and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for…
Read the full statement (148 words)
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 and manually entered temperature. The Genesis Touch Retrospective Physiological Monitoring System collects, displays and transmits vital signs measurements captured from commercially available FDA cleared wireless medical devices designed for home use. Collected measurement data from the Genesis Touch System can be transmited 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 adult and pediatric patients over twelve years of age 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112858: Genesis Touch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112858
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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