# K250135: WAVE Clinical Platform (2.0.000)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp/ Excel Medical
- Decided: Jan 16, 2026 after 364 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: 5 generations back to K122133 (2012). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171056: WAVE Clinical Platform, Excel Medical Electronics, LLC (2018) Summary page 6.

## 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 physiological data, waveforms, alarms, results, diagnostic and operational information routed through the platform from devices and systems using supported protocols. The WAVE Clinical Platform is intended for use in hospital and hospital type environments or where clinical consultations are needed. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes: » To remotely consult regarding patients’ conditions and statuses; * To remotely review other standard or critical patient and operational data, waveforms, alarms, and results to utilize this information to aid in clinical decisions. Warning: The WAVE Clinical Platform is intended to supplement and not 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/K250135
Methodology: https://510kreport.com/methodology