# K070204: Link to Acuity Clinician Notifier

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn Protocol, Inc.
- Decided: Mar 23, 2007 after 60 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: 5 generations back to K000647 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052160: Acuity Central Station, Model 020XXXXX (Note:  Xxxxx = Various Config.), Welch Allyn, Inc. (2005) Summary page 1.
- K052975: Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 Software, GE Healthcare (2006) Summary page 1.

## Indications for use
The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities. In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules: · The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and Mobile Acuity LT). * The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients. * The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients. * The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuity System patient printout files available on Web browsers) and HL7 options.

Source page: https://510kreport.com/device/K070204
Methodology: https://510kreport.com/methodology