# K082366: Lifebed Patient Vigilance System

- Pathway: 510(k) (Special)
- Applicant: Hoana Medical, Inc.
- Decided: Sep 26, 2008 after 39 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: 2 generations back to K992413 (1999). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052446: LG1 Intelligent Medical Vigilance System, Hoana Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K083534: Lifebed Network Patient Vigilance System (2009), 2 descendants of its own
- K100745: Lifebed Network Patient Vigilance System (2010), 0 descendants of its own
- K092037: Lifegurney Network Patient Vigilance System (2009), 0 descendants of its own

## Indications for use
The LifeBed Patient 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/K082366
Methodology: https://510kreport.com/methodology