# K083534: Lifebed Network Patient Vigilance System

- Pathway: 510(k) (Traditional)
- Applicant: Hoana Medical, Inc.
- Decided: Apr 13, 2009 after 136 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: 4 generations back to K915436 (1992). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 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.
- K082366: Lifebed Patient Vigilance System, Hoana Medical, Inc. (2008) Summary page 1.
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 4.
- K030763: Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System, Diagnostic Ultrasound Corp. (2003) Summary page 1.

## Most influential descendants
- 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 Network Patient Vigilance System is intended to measure heart rate, respiratory rate, and bed exit in adult patients for use by health care professionals.

Source page: https://510kreport.com/device/K083534
Methodology: https://510kreport.com/methodology