# K130339: Clinical Alert Notification

- Pathway: 510(k) (Traditional)
- Applicant: Extension, Inc.
- Decided: Jul 11, 2013 after 150 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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: 6 generations back to K962827 (1997). 7 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K103634: Ascom Clinicalconnex  Cardiomax, Ascom (Us), Inc. (2011) Summary page 1.

## Most influential descendants
- K152341: ViSi Mobile Monitoring System (2015), 4 descendants of its own
- K172586: Vios Monitoring System™ Model 2050 (2018), 2 descendants of its own
- K180472: ViSi Mobile Monitoring System (2018), 1 descendant of its own
- K241728: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (2025), 0 descendants of its own
- K232354: Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software (2024), 0 descendants of its own

## Indications for use
The EXTENSION Clinical Alert Notification solution is a closed loop communications system that interfaces with health care Information systems and medical devices to provide a secondary means of annunciating and displaying patient alarm text and other information to mobile health care workers that is Important to patient care, nursing vigilance and overall hospital operatlions. The EXTENSION Clinical Alert Notification solution alerts and informs the clinician about critical patient alarms by drawing an Identified individual's attention to a defined patient condition in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. The EXTENSION Clinical Alert Notification solution Is not Intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with the EXTENSION Clinical Alert Notification solution. The EXTENSION Clinical Alert Notification solution is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type acute care environments and Is not for home use.

Source page: https://510kreport.com/device/K130339
Methodology: https://510kreport.com/methodology