Cleared Traditional

K233409 - Eko Low Ejection Fraction Tool (ELEFT)

K233409 is an FDA 510(k) clearance for Eko Low Ejection Fraction Tool (ELEFT), manufactured by Eko Health, Inc.. The device is a Class 2 Cardiovascular device with product code QYE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K233409 · Eko Health, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
174d
Days
Class 2
Risk

K233409 is an FDA 510(k) clearance for the Eko Low Ejection Fraction Tool (ELEFT). Classified as Reduced Ejection Fraction Machine Learning-based Notification Software (product code QYE), Class II - Special Controls.

Submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on March 28, 2024 after a review of 174 days - an extended review cycle.

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 Eko Health, Inc. devices

FDA 510(k) Submission Details - K233409

510(k) Number K233409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2023
Decision Date March 28, 2024
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QYE Device Classification - Class 2, Special Controls

Product Code QYE Reduced Ejection Fraction Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up.
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 - QYE Reduced Ejection Fraction Machine Learning-based Notification Software

Devices cleared under the same product code (QYE) and FDA review panel - the closest regulatory comparables to K233409.
Bunkerhill ECG-EF
K250649 · BunkerHill Health · Sep 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
K250652 · Anumana, Inc. · Jul 2025
Tempus ECG-Low EF
K250119 · Tempus AI, Inc. · Jul 2025
Low Ejection Fraction AI-ECG Algorithm
K232699 · Anumana, Inc. · Sep 2023