Cleared Traditional

K232699 - Low Ejection Fraction AI-ECG Algorithm (FDA 510(k) Clearance)

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

K232699 · Anumana, Inc. · Cardiovascular device
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Sep 2023
Decision
23d
Days
Class 2
Risk

K232699 is an FDA 510(k) clearance for the Low Ejection Fraction AI-ECG Algorithm. Classified as Reduced Ejection Fraction Machine Learning-based Notification Software (product code QYE), Class II - Special Controls.

Submitted by Anumana, Inc. (Cambridge, US). The FDA issued a Cleared decision on September 28, 2023 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Anumana, Inc. devices

Submission Details

510(k) Number K232699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2023
Decision Date September 28, 2023
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K232699.
Bunkerhill ECG-EF
K250649 · BunkerHill Health · Sep 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
K250652 · Anumana, Inc. · Jul 2025
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Eko Low Ejection Fraction Tool (ELEFT)
K233409 · Eko Health, Inc. · Mar 2024