# K120774: Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT, Mobile Acuity, Mobile LT

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Apr 10, 2012 after 27 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925411 (1993). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K152701: Matrix Mini ECG Monitor (2016), 3 descendants of its own
- K171621: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor (2017), 2 descendants of its own
- K212473: Welch Allyn Connex Central Station (2022), 0 descendants of its own
- K201635: MouthLab Vital Signs Monitoring System (2021), 0 descendants of its own

## Indications for use
The Acuity® Central Monitoring Station is intendled 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 operational 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/K120774
Methodology: https://510kreport.com/methodology