510(k) · Cleared
ClearedConstant Care Lilah Home Health Monitoring System - Multi-User Version
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 15, 2013 as substantially equivalent to K120941 (Constant Care, LLC, 2012) after a 152-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Jul 15, 2013
- Review
- 152 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K040799 (2004). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK040799 Hommed Genesis Patient Monitor System with OptionsHommed, LLC · 2004
- 4 generations backK061087 Genesis Otc MonitorHoneywell Hommed, LLC · 2006
- 3 generations backK101242 Genesis DM Model: 6053000A1Honeywell Hommed, LLC · 2010
- 2 generations backK112858 Genesis Touch SystemHoneywell Hommed, LLC · 2012
- 1 generation backK120941 Constant Care Lilah Home Health Monitoring SystemConstant Care, LLC · 2012
- This deviceK130360 Constant Care Lilah Home Health Monitoring System - Multi-User VersionConstant Care, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K040799 | Hommed Genesis Patient Monitor System with Options | Hommed, LLC | 2004 | — |
| −4 | K061087 | Genesis Otc Monitor | Honeywell Hommed, LLC | 2006 | — |
| −3 | K101242 | Genesis DM Model: 6053000A1 | Honeywell Hommed, LLC | 2010 | — |
| −2 | K112858 | Genesis Touch System | Honeywell Hommed, LLC | 2012 | — |
| −1 | K120941 | Constant Care Lilah Home Health Monitoring System | Constant Care, LLC | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K120941 | Constant Care Lilah Home Health Monitoring SystemSummary page 2…cal in intended use and technological characteristics to the Constant Care LILAH Home Health Monitoring System (K120941), which is legally marketed by Constant Care, Results of software vali… | 2012 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 6 ancestors has a recall.
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. 2013, 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 LILAR 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 L]LAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for…
Read the full statement (306 words)
The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAR 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 L]LAH 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 wirless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, medication reminders, electronic thermometers, peak-flow meters anid pulse cximete-s. The Constant Care IIfAH 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-El, 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 medicall 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 contrindicated 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 anid the Constant Care website.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130360: Constant Care Lilah Home Health Monitoring System - Multi-User Version.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130360
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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