# K052160: Acuity Central Station, Model 020XXXXX (Note:  Xxxxx = Various Config.)

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Dec 16, 2005 after 129 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925411 (1993). 6 ancestors in all.
38 later devices descend from it; 6 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022453: Modification to Acuity Central Monitoring System, Welch Allyn Protocol, Inc. (2002) Summary page 1.
- K972121: Acuity Central Station, Protocol Systems, Inc. (1997) Summary page 1.
- K935846: Model Acuity Central Station, Protocol Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K101674: WVSM (Wireless Vital Signs Monitor), Model 5.0 (2010), 17 descendants of its own
- K113165: Mini-Medic (2012), 13 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K120343: Connex Workstation (2012), 7 descendants of its own
- K132807: Monitoring Station, Connex (R) Central Station (CS) (2014), 6 descendants of its own

## Recalls of this device
- May 16, 2011 · Not classified · Z-2918-2011: Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
- May 1, 2009 · Not classified · Z-0349-2011: The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display result

## Indications for use
The Acuity® Central Monitoring Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. 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 selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.

Source page: https://510kreport.com/device/K052160
Methodology: https://510kreport.com/methodology