Cleared Traditional

Etiometry Platform (DAV 5.4 RAE 9.2)

K241479 · Etiometry, Inc. · Cardiovascular
Feb 2025
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K241479 is an FDA 510(k) clearance for the Etiometry Platform (DAV 5.4 RAE 9.2), a Adjunctive Cardiovascular Status Indicator (Class II — Special Controls, product code PPW), submitted by Etiometry, Inc. (Boston, US). The FDA issued a Cleared decision on February 12, 2025, 264 days after receiving the submission on May 24, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2200.

Submission Details

510(k) Number K241479 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2024
Decision Date February 12, 2025
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PPW — Adjunctive Cardiovascular Status Indicator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2200
Definition The Adjunctive Cardiovascular Status Indicator Is A Prescription Device Based On Sensor Technology For The Measurement Of A Physical Parameter(s). This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.