Cardiovascular · 510(k) · 2025
Bunkerhill ECG-EF
BunkerHill Health. Cleared by FDA on 19 September 2025 under submission K250649, product code QYE (reduced ejection fraction machine learning-based notification software). What FDA's record says, in FDA's words.
Device record · K250649
- Device. Bunkerhill ECG-EFDEVICE
- Company. BunkerHill HealthCOMPANY
- Decision. 19 September 2025, 510(k), substantially equivalent (traditional review); received 4 March 2025DECISION
- Panel. CardiovascularPANEL
- Product code. QYE, Reduced Ejection Fraction Machine Learning-Based Notification SoftwareCODE
- Regulation. 21 CFR 870.2380, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Bunkerhill ECG-EF is software intended to aid in screening for Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for, but not already diagnosed with low LVEF. Bunkerhill ECG-EF is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non- invasive evaluation. Bunkerhill ECG-EF is adjunctive and must be interpreted in conjunction with the clinician’s judgment, the patient’s medical history, symptoms, and additional diagnostic tests. For a final clinical diagnosis, further confirmatory testing, such as echocardiography, is required.
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound, ECG
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QYE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QYE, in Cardiovascular, from BunkerHill Health, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.