FDA product code SBQ: Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
SBQ is the FDA product code for atrial fibrillation risk prediction 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 SBQ, 1 in the last five years. The average 510(k) review took 231 days (median 231); 231 days on average over the last three years.
Definition
Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Atrial Fibrillation Risk Prediction 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 SBQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 231 |
Compare with all 510(k) review times · Search every SBQ clearance
Top SBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tempus AI, Inc. | 1 | 2024-06-21 |
Most recent SBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233549 | Tempus AI, Inc. | Tempus ECG-AF | 2024-06-21 | 231 |
Recalls for SBQ devices
openFDA lists no recalls for product code SBQ.
Frequently asked questions
What is FDA product code SBQ?
SBQ is the FDA product code for atrial fibrillation risk prediction 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 SBQ?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code SBQ?
Across 1 cleared submissions the average was 231 days from receipt to decision (median 231).
Which companies have the most SBQ clearances?
Tempus AI, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBQ
- Run a recall and safety report across every SBQ manufacturer
- Watch product code SBQ 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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