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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 a medical device manufactured by Baxter Healthcare Corp/ Excel Medical. It received FDA 510(k) clearance on 2026-01-16 under approval 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. It is manufactured by Baxter Healthcare Corp/ Excel Medical. The 510(k) number is K250135.

When was WAVE Clinical Platform (2.0.000) approved by the FDA?

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

What company makes WAVE Clinical Platform (2.0.000)?

WAVE Clinical Platform (2.0.000) is manufactured by Baxter Healthcare Corp/ Excel Medical.

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.

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Related PubMed Literature

PMID: 41790854 A Substance Use Disorder Virtual Treatment and Research Platform: A Proof of Concept. IEEE pulse (2025)

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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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