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FDA 510(k)

Etiometry Platform

K-Number: K254066 · 2026-04-03

ApplicantEtiometry, Inc.
Decision Date2026-04-03
Product CodePPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Etiometry Platform is a medical device manufactured by Etiometry, Inc.. It received FDA 510(k) clearance on 2026-04-03 under approval number K254066. The device is classified under product code PPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Etiometry Platform?

Etiometry Platform is a medical device that received FDA 510(k) clearance on 2026-04-03. It is manufactured by Etiometry, Inc.. The 510(k) number is K254066.

When was Etiometry Platform approved by the FDA?

Etiometry Platform received FDA 510(k) clearance on 2026-04-03, under approval number K254066.

What company makes Etiometry Platform?

Etiometry Platform is manufactured by Etiometry, Inc..

What is the FDA product code for Etiometry Platform?

The FDA product code for Etiometry Platform is PPW.

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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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