510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250649Substantially Equivalent

Bunkerhill ECG-EF

Bunkerhill Health, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250649 is the FDA 510(k) clearance record for Bunkerhill ECG-EF, a class II device, cleared for BunkerHill Health on under FDA product code QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software). FDA's definition for product code QYE reads: "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". FDA records list 8 510(k) clearances for BunkerHill Health, from to . As of , FDA records show no recalls naming K250649.

Clearance record

Decision date
Received
(199 days to decision)
Product code
QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Regulation
21 CFR 870.2380
Device class
Class II
Review panel
Cardiovascular
Applicant
BunkerHill Health 436 Bryant St., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYE

Trailing 12 months

FDA records hold no clearances under product code QYE in the trailing twelve months.

FDA records show no clearances under product code QYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260