# K220117: ARC Intensive Care Information System (ARC System)

- Pathway: 510(k) (Traditional)
- Applicant: Ordinatrum Solutions
- Decided: Jun 6, 2023 after 508 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: 29 generations back to K941811 (1994). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142106: Decisio Health Patient Dashboard, Decisio Health, Inc. (2015) Summary page 6.

## Indications for use
The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiologic and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring. The ARC System software is intended to be used by healthcare professionals for the following purposes: • To remotely consult, regarding a patient's status • To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care • To create and manage Patient Prioritization Rules • To access Patient Prioritization information WARNING: • Rx Only. • Do not use the ARC System as an active patient monitoring. • Do not use the ARC System to replace any part of the hospital's device monitoring. • Do not rely on the ARC System software as the sole source of patient status information.

Source page: https://510kreport.com/device/K220117
Methodology: https://510kreport.com/methodology