# K022453: Modification to Acuity Central Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn Protocol, Inc.
- Decided: Aug 21, 2002 after 26 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925411 (1993). 5 ancestors in all.
63 later devices descend from it; 5 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913193: Model 100 Central Station, Protocol Systems, Inc. (1991) Summary page 1.
- K935846: Model Acuity Central Station, Protocol Systems, Inc. (1994) Summary page 1.
- K972121: Acuity Central Station, Protocol Systems, Inc. (1997) Summary page 1.
- K002725: Micropaq, Models 402 and 404, Protocol Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K052160: Acuity Central Station, Model 020XXXXX (Note:  Xxxxx = Various Config.) (2005), 38 descendants of its own
- K122036: Visi Mobile Monitoring System (2012), 20 descendants of its own
- K133586: Visi Mobile Monitioring System (2013), 18 descendants of its own
- K143751: Visi Mobile Monitoring System (2015), 17 descendants of its own
- K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0 (2010), 17 descendants of its own

## Recalls of this device
- Dec 31, 2003 · Not classified · Z-0538-04: Potential failure to audibly alarm due to speaker hardware component failure.

## Indications for use
The Acuity system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity Central Monitoring Station, Acuity software, FlexNet communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central monitoring station through the Acuity FlexNet communication network. In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis. Full Disclosure stores patient data for up to 96 hours. Arrhythmia monitoring 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 module is not intended for use with neonatal patients. ST analysis module provides real-time monitoring and alarms for ST segment deviations, from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each detected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients. The most likely locations for patients monitored by an Acuity system are step-down units, telemetry departments, general medsurg floors and emergency departments. The Acuity system is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K022453
Methodology: https://510kreport.com/methodology