Cleared Traditional

WAVE Clinical Platform (2.0.000)

K250135 · Baxter Healthcare Corp/ Excel Medical · Cardiovascular

Jan 2026

Decision

364d

Days

Class 2

Risk

About This 510(k) Submission

K250135 is an FDA 510(k) clearance for the WAVE Clinical Platform (2.0.000), a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Baxter Healthcare Corp/ Excel Medical (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 16, 2026, 364 days after receiving the submission on January 17, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K250135 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2025
Decision Date	January 16, 2026
Days to Decision	364 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300