510(k) · Cleared
ClearedLG1 Intelligent Medical Vigilance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoana Medical, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Feb 2, 2006 as substantially equivalent to K992413 (Medical Data Electronics, 1999) after a 148-day review. Its family tree reaches back 1 generation to 1999. 26 later devices descend from it.
- Decided
- Feb 2, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992413 (1999). 26 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK992413 Escort 100/300 Series B (Escort II) Patient MonitorMedical Data Electronics · 1999
- This deviceK052446 LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 2006
- Descendant · cites it directly · 21 of its ownK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- Descendant · 2 generations on · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · 2 generations on · 9 of its ownK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- Descendant · 3 generations on · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- Descendant · 4 generations on · 7 of its ownK131379 EarlysenseEarlysense, Ltd. · 2013
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009 · cites it directly21descendants
- K092062Everon 1.0Earlysense, Ltd. · 2010 · 2 generations on10descendants
- K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021 · 2 generations on9descendants
- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · 3 generations on9descendants
- K131379EarlysenseEarlysense, Ltd. · 2013 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992413 | Escort 100/300 Series B (Escort II) Patient Monitor | Medical Data Electronics | 1999 | — |
| 0 (this device) | K052446 | LG1 Intelligent Medical Vigilance System | Hoana Medical, Inc. | 2006 | — |
| +1 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| +2 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +2 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| +3 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| +4 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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 |
|---|---|---|---|
| * | K992413 | Escort 100/300 Series B (Escort II) Patient MonitorSummary page 1…74DRT, 870.2300 Substantially Equivalent Devices: Escort 100/300 Series B Patient Monitor (K992413) Hill-Rom Advanta-Bed, Class I Exempt Description of the LG1 Intelligent Medical V… | 1999 |
| * | — | Hill-Rom Advanta-Bed Named without a submission number |
What descends from it? (26)
See all 264 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?
- Its one ancestor has no recall.
- Of its descendants, K082626 (Wireless 2000 RF & Uwb Technologies, Ltd., 2009) has gone furthest, with 21 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The LG1TM Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care hospital environment. The system will also monitor bed exit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052446: LG1 Intelligent Medical Vigilance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052446
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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