# K233133: Talis EMR with Talis +ACG (Talis EMR with +ACG)

- Pathway: 510(k) (Traditional)
- Applicant: Talis Clinical, LLC
- Decided: Apr 1, 2024 after 187 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K941811 (1994). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213335: Capsule Surveillance System, Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. (2022) Summary page 4.

## Indications for use
+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems. Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility’s clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility’s efforts to improve compliance to their patient care protocols and achievement of their quality initiatives. It is not intended to replace clinicians’ judgement, but rather to assist clinicians in making timely, informed decisions. +ACG is not intended to be used for secondary monitoring. +ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action. +ACG only works with Talis EMR Products.

Source page: https://510kreport.com/device/K233133
Methodology: https://510kreport.com/methodology