# K130234: Nuvon Vitals Charting System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvon, Inc.
- Decided: Mar 13, 2013 after 42 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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 K012171 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012171: Modification to: Argus System-Continuous Expert Care Network W/Smart Alrams, Visicu, Inc. (2001) Summary page 1.
- K121871: Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing, Airstrip Technologies, LP (2012) Summary page 1.

## Indications for use
The Nuvon Vitals Charting System is an accessory to the Nuvon VEGA System (K103125) and is intended to display patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology. The Nuvon Vitals Charting System is only intended to display physiologic and other patient information and intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitored devices from which it obtains its data. The Nuvon Vitals Charting System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.

Source page: https://510kreport.com/device/K130234
Methodology: https://510kreport.com/methodology