Cleared Traditional

Bunkerhill ECG-EF

K250649 · BunkerHill Health · Cardiovascular
Sep 2025
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K250649 is an FDA 510(k) clearance for the Bunkerhill ECG-EF, a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II — Special Controls, product code QYE), submitted by BunkerHill Health (San Francisco, US). The FDA issued a Cleared decision on September 19, 2025, 199 days after receiving the submission on March 4, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2380.

Submission Details

510(k) Number K250649 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2025
Decision Date September 19, 2025
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QYE — Reduced Ejection Fraction Machine Learning-based Notification Software
Device Class Class II — 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.