DeviceClearance

Product code QYE— Cardiovascular

Bunkerhill ECG-EF

Classification name
Reduced Ejection Fraction Machine Learning-Based Notification Software
Device class
Class 2
Regulation
21 CFR 870.2380
Advisory panel
Cardiovascular
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QYE under 21 CFR 870.2380, via openFDA

Market context for product code QYE

FDA has cleared 5 devices under product code QYE between 2023 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QYE

Recent clearances under product code QYE

Data sourced from openFDA. This site is unofficial and independent of the FDA.