Cleared Traditional

EchoNext (K260332) - FDA 510(k) Clearance

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

K260332 · Pathwai, Inc. · Cardiovascular device
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Jun 2026
Decision
126d
Days
Class 2
Risk

K260332 is an FDA 510(k) clearance for the EchoNext. Classified as Cardiovascular Machine Learning-based Notification Software (product code QXO), Class II - Special Controls.

Submitted by Pathwai, Inc. (New York, US). The FDA issued a Cleared decision on June 8, 2026 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2380 - 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 Pathwai, Inc. devices

Submission Details

510(k) Number K260332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2026
Decision Date June 08, 2026
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXO Cardiovascular Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Cardiovascular Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Cardiovascular Disease Or Condition For Further Referral Or Diagnostic Follow-up. The Software Identifies A Single Condition Based On One Or More Non-invasive Physiological Inputs As Part Of Routine Medical Care. It Is Intended As The Basis For Further Testing And Is Not Intended To Provide Diagnostic Quality Output. It Is Not Intended To Identify Or Detect Arrhythmias.
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 - QXO Cardiovascular Machine Learning-based Notification Software

Devices cleared under the same product code (QXO) and FDA review panel - the closest regulatory comparables to K260332.
Viz HCM
DEN230003 · Viz. Ai, Inc. · Aug 2023