510(k) · Cardiovascular

Bunkerhill ECG-EF

by BunkerHill Health

Bunkerhill ECG-EF is an AI-enabled medical device from BunkerHill Health that the U.S. FDA cleared through 510(k) K250649 on September 19, 2025. Its lead review panel is Cardiovascular and its primary product code is QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software).

See also FDA-cleared AI cardiovascular devices in 2025, all FDA AI clearances in 2025, top cardiovascular AI devices.

Key facts

Submission numberK250649
Pathway510(k)
Date of final decision
Company (FDA list)BunkerHill Health
Lead review panelCardiovascular
Primary product codeQYE — Reduced Ejection Fraction Machine Learning-Based Notification Software
Applicant (openFDA)BunkerHill Health
Applicant locationSan Francisco, CA, US
Device classClass 2
Regulation number21 CFR 870.2380
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Bunkerhill ECG-EF went through this pathway (K250649).

openFDA lists it as a Class 2 device under 21 CFR 870.2380. Class II devices are moderate risk and are subject to general and special controls.

Product code QYE covers 5 devices on the FDA AI list. By decision date, this device is #5 of 5 under that code. BunkerHill Health has 8 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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