Cleared Traditional

K250135 - WAVE Clinical Platform (2.0.000) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250135 · Baxter Healthcare Corp/ Excel Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
364d
Days
Class 2
Risk

K250135 is an FDA 510(k) clearance for the WAVE Clinical Platform (2.0.000). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp/ Excel Medical (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 16, 2026 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp/ Excel Medical devices

Submission Details

510(k) Number K250135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 125d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 304
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K250135.
c-med0 alpha
K253436 · Cosinuss GmbH · Apr 2026
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · Fysicon BV · Aug 2025
Empatica Health Monitoring Platform
K242737 · Empatica S.R.L. · Jun 2025
WARD-CSS (v1.2.x)
K241958 · Ward 24/7 Aps · Feb 2025
iCare APP
K243146 · Ihealth Labs, Inc. · Feb 2025
Welch Allyn Connex® Spot Monitor
K241411 · Welch Allyn, Inc. · Dec 2024