FDA product code QXO: Cardiovascular Machine Learning-Based Notification Software
QXO is the FDA product code for cardiovascular 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 1 510(k) submission under QXO, 1 in the last five years. The average 510(k) review took 126 days (median 126); 126 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.
Classification
| Field | Value |
|---|---|
| Device name | Cardiovascular 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 QXO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 126 |
Compare with all 510(k) review times · Search every QXO clearance
Top QXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pathwai, Inc. | 1 | 2026-06-08 |
Most recent QXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260332 | Pathwai, Inc. | EchoNext | 2026-06-08 | 126 |
Recalls for QXO devices
openFDA lists no recalls for product code QXO.
Frequently asked questions
What is FDA product code QXO?
QXO is the FDA product code for cardiovascular 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 QXO?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXO?
Across 1 cleared submissions the average was 126 days from receipt to decision (median 126).
Which companies have the most QXO clearances?
Pathwai, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QXO
- Run a recall and safety report across every QXO manufacturer
- Watch product code QXO 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.
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