# K110809: Wireless Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 303, Inc.
- Decided: Jul 5, 2011 after 104 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K941811 (1994). 116 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052961: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors, with 802.11 Wireless Lan, Philips Medical Systems (2005) Summary page 1.
- K071058: Multiple Patient Receiver, Model Org-9700A, Nihon Kohden America, Inc. (2007) Summary page 1.

## Most influential descendants
- K132447: Vitalconnect Platform by Vital Connect Inc. (2014), 1 descendant of its own
- K191870: VV330 Continuous ECG Platform, VivaLNK Adhesive Patch (2020), 0 descendants of its own

## Indications for use
The Wireless Monitoring System is intended for use by health care professionals for routine surveillance of patient physiological parameters to include, pulse rate, respiratory rate and axillary temperature, in a hospital setting. Data is transmitted wirelessly to a central location. Notifications can be prospectively set to notify healthcare professionals to excursions outside of selected parameters. The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older.

Source page: https://510kreport.com/device/K110809
Methodology: https://510kreport.com/methodology