# K171056: WAVE Clinical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Excel Medical Electronics, LLC
- Decided: Jan 4, 2018 after 269 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: 4 generations back to K122133 (2012). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140339: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Covidien (2014) Summary page 5.

## Most influential descendants
- K250135: WAVE Clinical Platform (2.0.000) (2026), 0 descendants of its own

## Indications for use
The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS). The WAVE Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed through the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital or hospital type environments. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes: * To remotely consult regarding patients’ statuses; * To remotely review other standard or critical near real-time patient data, waveforms, alarms, and results in order to utilize this information to aid in clinical decisions. Warning: The WAVE Clinical Platform is intended to supplement and not to replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.

Source page: https://510kreport.com/device/K171056
Methodology: https://510kreport.com/methodology