# K143304: Sickbay Clinical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medical Informatics Corp
- Decided: May 26, 2015 after 189 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: 3 generations back to K122133 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132604: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Covidien (2013) Summary page 4.

## Indications for use
The Sickbay Clinical Platform is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (EMR) and Clinical Information Systems. The Sickbay Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Sickbay Clinical Platform for supported devices. The Sickbay Clinical Platform is intended to be used by healthcare professionals in a hospital setting for the following purposes: x To remotely consult, regarding a patient's status x 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 in a timely manner. WARNING: The Sickbay Clinical Platform is intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Sickbay Clinical Platform product as the sole source of alarms.

Source page: https://510kreport.com/device/K143304
Methodology: https://510kreport.com/methodology