510(k) Report

510(k) · Cleared

Cleared

Genesis Touch System

K141792510(k) TraditionalCleared Nov 25, 2014146-day reviewClass II21 CFR 870.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Honeywell Hommed · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Nov 25, 2014 as substantially equivalent to K101242 (Honeywell Hommed, LLC, 2010) and 1 other predicate after a 146-day review. Its family tree reaches back 4 generations to 2004.

Decided
Nov 25, 2014
Review
146 days
Class
Class II
Product code
DRG
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K040799 (2004). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK040799 · Hommed Genesis Patient Monitor System with Options · Hommed, LLC · 2004K061087 · Genesis Otc Monitor · Honeywell Hommed, LLC · 2006K101242 · Genesis DM Model: 6053000A1 · Honeywell Hommed, LLC · 2010K112858 · Genesis Touch System · Honeywell Hommed, LLC · 20122000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor K112858 · Genesis Touch System · Honeywell Hommed, LLC · 2012K101242 · Genesis DM Model: 6053000A1 · Honeywell Hommed, LLC · 2010K061087 · Genesis Otc Monitor · Honeywell Hommed, LLC · 2006K040799 · Hommed Genesis Patient Monitor System with Options · Hommed, LLC · 20040
  1. Root · 4 generations backK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
  2. 3 generations backK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
  3. 2 generations backK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
  4. 1 generation backK112858 Genesis Touch SystemHoneywell Hommed, LLC · 2012
  5. This deviceK141792 Genesis Touch SystemHoneywell Hommed · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K040799Hommed Genesis Patient Monitor System with OptionsHommed, LLC2004—
−3K061087Genesis Otc MonitorHoneywell Hommed, LLC2006—
−2K101242Genesis DM Model: 6053000A1Honeywell Hommed, LLC2010—
−1K112858Genesis Touch SystemHoneywell Hommed, LLC2012—
0 (this device)K141792Genesis Touch SystemHoneywell Hommed2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K141792, 2004–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K101242Genesis DM Model: 6053000A1
Summary page 4
…, Spirometry II 864.7750 GJS Test, Time, Prothrombin II Predicate Device(s): Honeywell HomMed Genesis DM Pro BP, K101242; Honeywell HomMed Genesis Touch System, K112858 510(k) Summary…
Honeywell Hommed, LLC2010—
*K112858Genesis Touch System
Summary page 4
…e, Prothrombin II Predicate Device(s): Honeywell HomMed Genesis DM Pro BP, K101242; Honeywell HomMed Genesis Touch System, K112858 510(k) Summary K1417…
Honeywell Hommed, LLC2012—

Also cleared against K101242: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • None of the 5 ancestors has a recall.
  • 4 other devices also cite its predicate K101242.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—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, temperature, blood sugar, prothrombin time/international normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1). The Genesis Touch Retrospective Physiological Monitoring System collects; displays and…

Read the full statement (153 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, temperature, blood sugar, prothrombin time/international

normalized ratio (PT/INR), peak expiratory flow (PEF) and forced expiratory volume (FEV1).

The Genesis Touch Retrospective Physiological Monitoring System collects; displays and

transmits vital signs measurements from commercially available medical devices designed for

home use. Collected measurement data from the Genesis Touch System can then be transmitted

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

patients and caregivers 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.

Also cleared against K101242

4 other devices cite the same predicate.

  • K132930Myhealthpoint Telehealth ManagerEntra Health Systems · 2014
  • K120325Connected Care Mobile ApplicationWatermark Medical · 2012
  • K112858Genesis Touch SystemHoneywell Hommed, LLC · 2012
  • K103214M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc. · 2010

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https://510kreport.com/device/K141792 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141792: 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/K141792

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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