Cleared Traditional

K254302 - ECG Analysis Software (AiTiALVSD)

K254302 is an FDA 510(k) clearance for ECG Analysis Software (AiTiALVSD), manufactured by Medical AI Co., Ltd.. The device is a Class 2 Cardiovascular device with product code QYE cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K254302 · Medical AI Co., Ltd. · Cardiovascular device
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Sep 2026
Decision
273d
Days
Class 2
Risk

K254302 is an FDA 510(k) clearance for the ECG Analysis Software (AiTiALVSD). Classified as Reduced Ejection Fraction Machine Learning-based Notification Software (product code QYE), Class II - Special Controls.

Submitted by Medical AI Co., Ltd. (Gangnam-Gu, Seoul, KR). The FDA issued a Cleared decision on September 30, 2026 after a review of 273 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 Medical AI Co., Ltd. devices

FDA 510(k) Submission Details - K254302

510(k) Number K254302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date September 30, 2026
Days to Decision 273 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
148d slower than avg
Panel avg: 125d · This submission: 273d
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 K254302.
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
Eko Low Ejection Fraction Tool (ELEFT)
K233409 · Eko Health, Inc. · Mar 2024
Low Ejection Fraction AI-ECG Algorithm
K232699 · Anumana, Inc. · Sep 2023