DeviceClearance

Etiometry Platform— 510(k) K254066

Substantially Equivalent

Etiometry, Inc.

FDA 510(k) clearance K254066 for Etiometry Platform, Substantially Equivalent on 2026-04-03. Applicant: Etiometry, Inc.. Device class: 2.

Summary

Etiometry's Etiometry Platform is filed under product code PPW (Adjunctive Cardiovascular Status Indicator). The record doesn't describe the platform beyond its name and that code name.

Class II, 21 CFR 870.2200. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).

Etiometry filed from Dedham, Massachusetts. The record shows 106 calendar days from receipt to decision (December 18, 2025 to April 3, 2026).

Clearance details

Applicant
Etiometry, Inc.
Product code
Product code PPW
Device class
Class 2
Regulation
21 CFR 870.2200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Dedham, MA, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.