Cleared Traditional

K241479 - Etiometry Platform (DAV 5.4 RAE 9.2) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K241479 is an FDA 510(k) clearance for the Etiometry Platform (DAV 5.4 RAE 9.2). Classified as Adjunctive Cardiovascular Status Indicator (product code PPW), Class II - Special Controls.

Submitted by Etiometry, Inc. (Boston, US). The FDA issued a Cleared decision on February 12, 2025 after a review of 264 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Etiometry, Inc. devices

Submission Details

510(k) Number K241479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PPW Adjunctive Cardiovascular Status Indicator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PPW Adjunctive Cardiovascular Status Indicator

All 7
Devices cleared under the same product code (PPW) and FDA review panel - the closest regulatory comparables to K241479.
Etiometry Platform
K254066 · Etiometry, Inc. · Apr 2026
prolaio eVO2peak Module (Version 1.0)
K252204 · Prolaio, Inc. · Dec 2025
T3 Platform software
K223578 · Etiometry, Inc. · Jul 2023
T3 Platform Software
K213230 · Etiometry, Inc. · Jun 2022
CipherOx CRI Tablet
K213255 · Flashback Technologies, Inc. · Jun 2022