Bunkerhill ECG-EF
FDA 510(k) K250649 · BunkerHill Health
510(k) numberK250649
Submission
- Device name
- Bunkerhill ECG-EF
- Applicant
- BunkerHill Health
San Francisco, CA, US - Received
- March 4, 2025
- Decision date
- September 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYE – Reduced Ejection Fraction Machine Learning-Based Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2380
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code QYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional | Anumana, Inc. | 07/28/2025SE |
| K250119 | Tempus ECG-Low EFQYE · Traditional | Tempus AI, Inc. | 07/15/2025SE |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT)QYE · Traditional | Eko Health, Inc. | 03/28/2024SE |
| K232699 | Low Ejection Fraction AI-ECG AlgorithmQYE · Traditional | Anumana, Inc. | 09/28/2023SE |
More from Anumana, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260167 | Bunkerhill Contrast AVCJAK · Traditional | 03/06/2026SE |
| K260166 | Bunkerhill Contrast CACJAK · Traditional | 03/06/2026SE |
| K250662 | Bunkerhill MACJAK · Traditional | 10/03/2025SE |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ)QIH · Traditional | 07/01/2025SE |
| K242295 | BunkerHill BMDKGI · Traditional | 04/08/2025SE |
| K243229 | Bunkerhill AVCJAK · Traditional | 01/27/2025SE |
| K240369 | CAC (gated) AlgorithmJAK · Traditional | 09/27/2024SE |
Questions and answers
When was Bunkerhill ECG-EF cleared by the FDA?
Bunkerhill ECG-EF (K250649) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 199 days after the submission was received.
What is the product code of K250649?
The FDA product code is QYE – Reduced Ejection Fraction Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.