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FDA 510(k)

WAVE Clinical Platform (2.0.000)

K-Number: K250135 · 2026-01-16

ApplicantBaxter Healthcare Corp/ Excel Medical
Decision Date2026-01-16
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WAVE Clinical Platform (2.0.000) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp/ Excel Medical. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K250135. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVE Clinical Platform (2.0.000)?

WAVE Clinical Platform (2.0.000) is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Baxter Healthcare Corp/ Excel Medical. The 510(k) number is K250135.

When did WAVE Clinical Platform (2.0.000) receive FDA 510(k) clearance?

WAVE Clinical Platform (2.0.000) received FDA 510(k) clearance on 2026-01-16, under 510(k) number K250135.

Who is the listed applicant for WAVE Clinical Platform (2.0.000)?

The FDA 510(k) record lists Baxter Healthcare Corp/ Excel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVE Clinical Platform (2.0.000)?

The FDA product code for WAVE Clinical Platform (2.0.000) is MWI.

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BVK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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