FDA product code QYE: Reduced Ejection Fraction Machine Learning-Based Notification Software
QYE is the FDA product code for reduced ejection fraction machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under QYE, 5 in the last five years, from 4 different applicants. The average 510(k) review took 144 days (median 174); 174 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Reduced Ejection Fraction Machine Learning-Based Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 870.2380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QYE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 23 |
| 2024 | 1 | 174 |
| 2025 | 3 | 175 |
Compare with all 510(k) review times · Search every QYE clearance
Top QYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anumana, Inc. | 2 | 2025-07-28 |
| BunkerHill Health | 1 | 2025-09-19 |
| Tempus AI, Inc. | 1 | 2025-07-15 |
| Eko Health, Inc. | 1 | 2024-03-28 |
Most recent QYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250649 | BunkerHill Health | Bunkerhill ECG-EF | 2025-09-19 | 199 |
| K250652 | Anumana, Inc. | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | 2025-07-28 | 146 |
| K250119 | Tempus AI, Inc. | Tempus ECG-Low EF | 2025-07-15 | 180 |
| K233409 | Eko Health, Inc. | Eko Low Ejection Fraction Tool (ELEFT) | 2024-03-28 | 174 |
| K232699 | Anumana, Inc. | Low Ejection Fraction AI-ECG Algorithm | 2023-09-28 | 23 |
Recalls for QYE devices
openFDA lists no recalls for product code QYE.
Frequently asked questions
What is FDA product code QYE?
QYE is the FDA product code for reduced ejection fraction machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel.
What device class is QYE?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYE?
Across 5 cleared submissions the average was 144 days from receipt to decision (median 174).
Which companies have the most QYE clearances?
Anumana, Inc. (2); BunkerHill Health (1); Tempus AI, Inc. (1); Eko Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYE
- Run a recall and safety report across every QYE manufacturer
- Watch product code QYE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times