FDA 510(k) · Welch Allyn
K120774: ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT (Welch Allyn, Inc.)
Welch Allyn, Inc. received FDA 510(k) K120774 for ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT, with a decision date of Apr 10, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K120774 |
|---|---|
| Pathway | 510(k) |
| Applicant | Welch Allyn, Inc. |
| Device name | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT |
| Product code | DSI: Detector And Alarm, Arrhythmia |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Mar 14, 2012 |
| Decision date | Apr 10, 2012 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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 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. Special 5 10O(k) Acuity® Central Monitoring Station
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DSI is "Detector And Alarm, Arrhythmia", class 2, 21 CFR 870.1025.
Our labels for filtering: claim AFib / irregular rhythm, sensor ECG electrodes. These are heuristics, not FDA fields.