# K972121: Acuity Central Station

- Pathway: 510(k) (Traditional)
- Applicant: Protocol Systems, Inc.
- Decided: Nov 7, 1997 after 155 days
- Product code: MLD (Monitor, St Segment With Alarm)
- 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: 1 generation back to K925411 (1993). 1 ancestor in all.
64 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925411: Model 2041-PC/ST Cardiac Telemetry Monitor, Accucore, Inc. (1993) Summary page 1.

## Most influential descendants
- K022453: Modification to Acuity Central Monitoring System (2002), 63 descendants of its own
- 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

## Indications for use
The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies. It is recommended for use with Adult and Pediatric patients one year or older. ST Analysis is automatically disabled when the corresponding Propaq Encore is in the Neonatal patient mode. It is intended for use by healthcare practitioners who know how to acquire and interpret patients’ vital signs and are trained in the use of the Acuity System and its components. The clinician is responsible for determining the clinical significance of each alarm generated by Acuity. As with all computerized ST Analysis systems, Acuity cannot replace skilled care and proper surveillance by a clinician. A clinician should review all data obtained from Acuity before implementing therapy based on this data.

Source page: https://510kreport.com/device/K972121
Methodology: https://510kreport.com/methodology