# K052446: LG1 Intelligent Medical Vigilance System

- Pathway: 510(k) (Traditional)
- Applicant: Hoana Medical, Inc.
- Decided: Feb 2, 2006 after 148 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992413 (1999). 1 ancestor in all.
26 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992413: Escort 100/300 Series B (Escort II) Patient Monitor, Medical Data Electronics (1999) Summary page 1.
- (no number) Hill-Rom Advanta-Bed: named in the summary without a submission number

## Most influential descendants
- K082626: PAM 3000 (2009), 21 descendants of its own
- K092062: Everon 1.0 (2010), 10 descendants of its own
- K202464: Vital Sign Monitoring Sensor (Model :XK300) (2021), 9 descendants of its own
- K120465: Earlysense (Everon) System (2012), 9 descendants of its own
- K131379: Earlysense (2013), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K052446
Methodology: https://510kreport.com/methodology