# K100745: Lifebed Network Patient Vigilance System

- Pathway: 510(k) (Special)
- Applicant: Hoana Medical, Inc.
- Decided: Apr 15, 2010 after 30 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: 5 generations back to K915436 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 2.
- K083534: Lifebed Network Patient Vigilance System, Hoana Medical, Inc. (2009) Summary page 1.
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 1.
- K030763: Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System, Diagnostic Ultrasound Corp. (2003) Summary page 1.

## Indications for use
The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

Source page: https://510kreport.com/device/K100745
Methodology: https://510kreport.com/methodology