510(k) · Cleared
ClearedConstant Care Lilah Home Health Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Constant Care, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 3, 2012 as substantially equivalent to K112858 (Honeywell Hommed, LLC, 2012) after a 96-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Jul 3, 2012
- Review
- 96 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040799 (2004). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
- 3 generations backK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
- 2 generations backK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
- 1 generation backK112858 Genesis Touch SystemHoneywell Hommed, LLC · 2012
- This deviceK120941 Constant Care Lilah Home Health Monitoring SystemConstant Care, LLC · 2012
- Descendant · cites it directly · 0 of its ownK130360 Constant Care Lilah Home Health Monitoring System - Multi-User VersionConstant Care, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K130360Constant Care Lilah Home Health Monitoring System - Multi-User VersionConstant Care, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040799 | Hommed Genesis Patient Monitor System with Options | Hommed, LLC | 2004 | — |
| −3 | K061087 | Genesis Otc Monitor | Honeywell Hommed, LLC | 2006 | — |
| −2 | K101242 | Genesis DM Model: 6053000A1 | Honeywell Hommed, LLC | 2010 | — |
| −1 | K112858 | Genesis Touch System | Honeywell Hommed, LLC | 2012 | — |
| 0 (this device) | K120941 | Constant Care Lilah Home Health Monitoring System | Constant Care, LLC | 2012 | — |
| +1 | K130360 | Constant Care Lilah Home Health Monitoring System - Multi-User Version | Constant Care, LLC | 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 |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K112858 | Genesis Touch System | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130360 | Constant Care Lilah Home Health Monitoring System - Multi-User Version | 2013 | 0 |
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 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K130360 (Constant Care, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112858.
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 Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for…
Read the full statement (298 words)
The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology.
The Constant Care LILAH Home Health Monitoring System connects to commercially available wireless and wired glucose meters, weight scales, blood pressure monitors, medication reminders, and pulse oximeters. The Constant Care LILAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless, Internet, or Ethernet.
Healthcare professionals and remote caregivers can review the transmitted information utilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded.
The Constant Care LILAH Home Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real-time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.
A list of devices that are compatible with the Constant Care LILAH Home Health Monitoring System will be available in the user's manual and the Constant Care website.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K120941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120941: Constant Care Lilah Home Health Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120941
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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